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U.S. Department of Health and Human Services

Drugs

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New and Generic Drug Approvals

 

August 28, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aleve Pm diphenhydramine hydrochloride; naproxen sodium Tablet;Oral Bayer Hlthcare Labeling Revision
Avonex interferon beta-1a Vial Biogen Labeling Revision
Decitabine decitabine Injectable;Injection Sandoz Inc Approval
Ella ulipristal acetate Tablet;Oral Lab Hra Pharma Labeling Revision
Frovatriptan Succinate frovatriptan succinate Tablet;Oral Mylan Pharms Inc Approval
Ifex ifosfamide Injectable;Injection Baxter Hlthcare Labeling Revision
Ifex/Mesnex Kit ifosfamide; mesna Injectable;Injection Baxter Hlthcare Labeling Revision
Lamivudine and Zidovudine lamivudine;zidovudine Tablet;Oral Mylan Pharms Inc Approval
Metformin Hydrochloride metformin hydrochloride Tablet;Oral Zydus Hlthcare Approval
Oxycodone; Acetaminophen oxycodone;acetaminophen Tablet;Oral Rhodes Pharms Approval
Requip ropinirole hydrochloride Tablet;Oral Glaxosmithkline Llc Labeling Revision
Requip Xl ropinirole hydrochloride Tablet, Extended Release;Oral Glaxosmithkline Llc Labeling Revision
Rimso-50 dimethyl sulfoxide Solution;Intravesical Mylan Institutional Manufacturing Change or Addition
Stavzor valproic acid Capsule, Delayed Release;Oral Banner Pharmacaps Labeling Revision
Stribild cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Efficacy Supplement with Clinical Data to Support

 

August 27, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Clonazepam clonazepam Tablet;Oral Sun Pharm Inds Inc Approval
Elelyso taliglucerase alfa Powder;Iv (Infusion) Pfizer Efficacy Supplement with Clinical Data to Support
Elelyso taliglucerase alfa Powder;Iv (Infusion) Pfizer Labeling Revision
Ella ulipristal acetate Tablet;Oral Lab Hra Pharma Labeling Revision
Megestrol Acetate megestrol acetate Suspension;Oral Twi Pharms Inc Approval
Metoprolol Tartrate metoprolol tartrate Injectable;Injection Gland Pharma Ltd Approval
Nephramine 5.4% amino acids Injectable;Injection B Braun Manufacturing Change or Addition
Olopatadine Hydrochloride olopatadine hydrochloride Solution;Ophthalmic Watson Labs Inc Tentative Approval
Phoslyra calcium acetate Solution;Oral Fresenius Medcl Manufacturing Change or Addition
Vimovo esomeprazole magnesium; naproxen Tablet, Delayed Release;Oral Horizon Pharma Manufacturing Change or Addition
Xopenex Hfa levalbuterol tartrate Aerosol, Metered;Inhalation Sunovion Manufacturing Change or Addition

 

August 26, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Dostinex cabergoline Tablet;Oral Pharmacia and Upjohn Labeling Revision
Entecavir entecavir Tablet;Oral Teva Pharms Usa Approval
Furosemide furosemide Injectable;Injection Emcure Pharms Ltd Approval
Memantine Hydrochloride memantine hydrochloride Tablet;Oral Macleods Pharms Ltd Tentative Approval
Nevirapine nevirapine Tablet, Extended Release;Oral Mylan Labs Ltd Tentative Approval
Primaxin cilastatin sodium; imipenem Injectable;Injection Merck Manufacturing Change or Addition
Promacta eltrombopag olamine Tablet;Oral Glaxosmithkline Efficacy Supplement with Clinical Data to Support
Telmisartan telmisartan Tablet;Oral Zydus Pharms Usa Inc Approval
Telmisartan and Amlodipine telmisartan;amlodipine Tablet;Oral Mylan Pharms Inc Approval
Xalkori crizotinib Capsule;Oral Pf Prism Cv Manufacturing Change or Addition

 

August 25, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Bacitracin bacitracin Injectable;Injection Xellia Pharms Aps Approval
Buspirone Hydrochloride buspirone hydrochloride Tablet;Oral Strides Arcolab Ltd Approval
Diabeta glyburide Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Faslodex fulvestrant Injectable;Intramuscular Astrazeneca Manufacturing Change or Addition
Invega Sustenna paliperidone palmitate Suspension, Extended Release;Intramuscular Janssen Pharms Manufacturing Change or Addition
Kabiven and Perikabiven amino acids;electrolytes;dextrose;lipid Injectable;Injection Fresenius Kabi Approval
Membraneblue trypan blue Solution;Ophthalmic Dorc Manufacturing Change or Addition
Oxacillin Sodium oxacillin sodium Injectable;Injection Agila Speclts Approval
Tafinlar dabrafenib mesylate Capsule;Oral Glaxosmithkline Manufacturing Change or Addition
Tricor fenofibrate Tablet;Oral Abbvie Manufacturing Change or Addition
Visionblue trypan blue Solution;Ophthalmic Dorc Manufacturing Change or Addition

 

August 22, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Ampyra dalfampridine Tablet, Extended Release;Oral Acorda Manufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.11% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.2% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.33% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.45% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 10% and Sodium Chloride 0.9% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 10% In Plastic Container dextrose Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.11% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.2% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.33% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 2.5% and Sodium Chloride 0.9% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 2.5% In Half-Strength Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 2.5% In Plastic Container dextrose Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 4% In Modified Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.11% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.2% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.33% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 5% In Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 5% In Plastic Container dextrose Injectable;Injection B Braun Manufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.45% In Plastic Container dextrose; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Dextrose 7.7% In Plastic Container dextrose Injectable;Injection B Braun Manufacturing Change or Addition
Fexofenadine Hydrochloride fexofenadine hydrochloride Tablet;Oral Aurolife Pharma Llc Tentative Approval
Gilenya fingolimod Capsule;Oral Novartis Manufacturing Change or Addition
Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable;Injection B Braun Manufacturing Change or Addition
Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container heparin sodium Injectable;Injection B Braun Manufacturing Change or Addition
Heparin Sodium 20,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable;Injection B Braun Manufacturing Change or Addition
Heparin Sodium 25,000 Units In Dextrose 5% In Plastic Container heparin sodium Injectable;Injection B Braun Manufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container heparin sodium Injectable;Injection B Braun Manufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable;Injection B Braun Manufacturing Change or Addition
Lidocaine Hydrochloride 0.2% and Dextrose 5% In Plastic Container lidocaine hydrochloride Injectable;Injection B Braun Manufacturing Change or Addition
Lidocaine Hydrochloride 0.4% and Dextrose 5% In Plastic Container lidocaine hydrochloride Injectable;Injection B Braun Manufacturing Change or Addition
Lidocaine Hydrochloride 0.8% and Dextrose 5% In Plastic Container lidocaine hydrochloride Injectable;Injection B Braun Manufacturing Change or Addition
Midazolam Hydrochloride midazolam hydrochloride Injectable;Injection Bd Rx Approval
Minocycline Hydrochloride minocycline hydrochloride Tablet, Extended Release;Oral Mylan Pharms Inc Approval
Minocycline Hydrochloride minocycline hydrochloride Tablet, Extended Release;Oral Mylan Pharms Inc Tentative Approval
Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Dextrose 5% In Plastic Container dextrose; potassium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.037% In Sodium Chloride 0.9% In Plastic Container potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Dextrose 5% In Plastic Container dextrose; potassium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.075% In Sodium Chloride 0.9% In Plastic Container potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Dextrose 5% In Plastic Container dextrose; potassium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.11% In Sodium Chloride 0.9% In Plastic Container potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Dextrose 5% In Plastic Container dextrose; potassium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Container potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Dextrose 5% In Plastic Container dextrose; potassium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.22% In Sodium Chloride 0.9% In Plastic Container potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Dextrose 5% In Plastic Container dextrose; potassium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Potassium Chloride 0.3% In Sodium Chloride 0.9% In Plastic Container potassium chloride; sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Prinivil lisinopril Tablet;Oral Merck Manufacturing Change or Addition
Rivastigmine Tartrate rivastigmine tartrate Capsule;Oral Macleods Pharms Ltd Approval
Theophylline 0.04% and Dextrose 5% In Plastic Container theophylline Injectable;Injection B Braun Manufacturing Change or Addition
Theophylline 0.08% and Dextrose 5% In Plastic Container theophylline Injectable;Injection B Braun Manufacturing Change or Addition
Theophylline 0.16% and Dextrose 5% In Plastic Container theophylline Injectable;Injection B Braun Manufacturing Change or Addition
Theophylline 0.2% and Dextrose 5% In Plastic Container theophylline Injectable;Injection B Braun Manufacturing Change or Addition
Theophylline 0.32% and Dextrose 5% In Plastic Container theophylline Injectable;Injection B Braun Manufacturing Change or Addition
Theophylline 0.4% and Dextrose 5% In Plastic Container theophylline Injectable;Injection B Braun Manufacturing Change or Addition
Tobramycin tobramycin Solution;Inhalation, Nebulizer Pulmoflow Inc Tentative Approval
Triumeq abacavir sulfate;dolutegravir;lamivudine Tablet;Fixed-Dose, Combinatiion Viiv Hlthcare Approval
Uceris budesonide Tablet, Extended Release;Oral Santarus Inc Manufacturing Change or Addition
Zorvolex diclofenac Capsule;Oral Iroko Pharms Llc Efficacy Supplement with Clinical Data to Support

 

August 21, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride;hydrochlorothiazide Tablet;Oral Apotex Inc Approval
Duodote atropine; pralidoxime chloride Injectable;Intramuscular Meridian Medcl Manufacturing Change or Addition
Elidel pimecrolimus Cream;Topical Valeant Bermuda Manufacturing Change or Addition
Eliquis apixaban Tablet;Oral Bristol Myers Squibb Efficacy Supplement with Clinical Data to Support
Kazano alogliptin benzoate; metformin hydrochloride Tablet;Oral Takeda Pharms Usa Manufacturing Change or Addition
Levocetirizine Dihydrochloride levocetirizine dihydrochloride Solution;Oral Apotex Inc Approval
Potassium Chloride potassium chloride Tablet, Extended Release;Oral Mylan Pharms Inc Approval
Pralidoxime Chloride pralidoxime chloride Injectable;Injection Meridian Medcl Techn Manufacturing Change or Addition
Prepopik citric acid; magnesium oxide; sodium picosulfate For Solution;Oral Ferring Pharms As Manufacturing Change or Addition
Retin-A Micro tretinoin Gel;Topical Valeant Intl Manufacturing Change or Addition
Retin-A-Micro tretinoin Gel;Topical Valeant Intl Manufacturing Change or Addition
Revatio sildenafil citrate Solution;Intravenous Pfizer Manufacturing Change or Addition
Rifampin rifampin Injectable;Injection Fresenius Kabi Usa Approval
Sandostatin Lar octreotide acetate Injectable;Injection Novartis Manufacturing Change or Addition
Zoledronic Acid zoledronic acid Injectable;Injection Akorn Inc Approval

 

August 20, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adenoscan adenosine Injectable;Injection Astellas Labeling Revision
Arnuity Ellipta fluticasone furoate Powder;Inhalation Glaxosmithkline Approval
Clinolipid 20% olive oil; soybean oil Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Depacon valproate sodium Injectable;Injection Abbvie Labeling Revision
Depakene valproic acid Capsule;Oral Abbvie Labeling Revision
Depakene valproic acid Syrup;Oral Abbvie Labeling Revision
Depakote divalproex sodium Tablet, Delayed Release;Oral Abbvie Labeling Revision
Depakote divalproex sodium Capsule, Delayed Rel Pellets;Oral Abbvie Labeling Revision
Depakote Er divalproex sodium Tablet, Extended Release;Oral Abbvie Labeling Revision
Fulyzaq crofelemer Tablet, Delayed Release;Oral Salix Pharms Manufacturing Change or Addition
Hydroxyzine Hydrochloride hydroxyzine hydrochloride Tablet;Oral Emcure Pharms Usa Approval
Intelence etravirine Tablet;Oral Janssen R and D Labeling Revision
Levonorgestrel levonorgestrel Tablet;Oral Perrigo R and D Approval
Polyethylene Glycol 3350;Potassium Chloride;Sodium Bicarbonate;Sodium Chloride and Bisacodyl polyethylene glycol 3350;potassium chloride;sodium bicarbonate;sodium chloride;bisacodyl Solution;Oral and Tablet;Delayed Release Novel Labs Inc Approval
Pristiq desvenlafaxine succinate Tablet, Extended Release;Oral Wyeth Pharms Inc Approval
Radiogardase (Prussian Blue) ferric hexacyanoferrate(ii) Capsule;Oral Heyl Chemisch Labeling Revision

 

August 19, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Acyclovir acyclovir Tablet;Oral Zydus Pharms Usa Inc Approval
Ammonia N 13 ammonia n 13 Injectable;Injection Johns Hopkins Univ Approval
Avinza morphine sulfate Capsule, Extended Release;Oral King Pharms Llc Supplement
Butrans buprenorphine Film, Extended Release;Transdermal Purdue Pharma Lp Supplement
Cerdelga eliglustat Capsule; Oral Genzyme Corp Approval
Dolophine Hydrochloride methadone hydrochloride Syrup;Oral Roxane Supplement
Dolophine Hydrochloride methadone hydrochloride Tablet;Oral Roxane Supplement
Duragesic-100 fentanyl Film, Extended Release;Transdermal Janssen Pharms Supplement
Duragesic-12 fentanyl Film, Extended Release;Transdermal Janssen Pharms Supplement
Duragesic-25 fentanyl Film, Extended Release;Transdermal Janssen Pharms Supplement
Duragesic-50 fentanyl Film, Extended Release;Transdermal Janssen Pharms Supplement
Duragesic-75 fentanyl Film, Extended Release;Transdermal Janssen Pharms Supplement
Eliquis apixaban Tablet;Oral Bristol Myers Squibb Efficacy Supplement with Clinical Data to Support
Embeda morphine sulfate; naltrexone hydrochloride Capsule, Extended Release;Oral Alpharma Pharms Supplement
Exalgo hydromorphone hydrochloride Tablet, Extended Release;Oral Mallinckrodt Inc Supplement
Kadian morphine sulfate Capsule, Extended Release;Oral Watson Labs Inc Supplement
Ms Contin morphine sulfate Tablet, Extended Release;Oral Purdue Pharma Lp Supplement
Mycophenolic Acid mycophenolic acid Tablet, Delayed Release; Oral Apotex Inc Approval
Mycophenolic Acid mycophenolic acid Tablet, Delayed Release;Oral Apotex Inc Approval
Nucynta Er tapentadol hydrochloride Tablet, Extended Release;Oral Janssen Pharms Supplement
Opana Er oxymorphone hydrochloride Tablet, Extended Release;Oral Endo Pharms Supplement
Opana Er oxymorphone hydrochloride Tablet, Extended Release;Oral Endo Pharms Supplement
Oxycontin oxycodone hydrochloride Tablet, Extended Release;Oral Purdue Pharma Lp Supplement
Targiniq naloxone hydrochloride; oxycodone hydrochloride Tablet, Extended Release;Oral Purdue Pharma Lp Supplement
Zohydro Er hydrocodone bitartrate Capsule, Extended Release;Oral Zogenix Inc Labeling Revision

 

August 18, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Basaglar insulin glargine Injectable;Injection Eli Lilly and Co Tentative Approval
Cefazolin Sodium cefazolin sodium Injectable;Injection Acs Dobfar Chemistry New Strength
Dexmedetomidine Hydrochloride dexmedetomidine hydrochloride Injectable; Injection Mylan Institutional Approval
Dexmedetomidine Hydrochloride dexmedetomidine hydrochloride Injectable;Injection Par Sterile Products Approval
Docetaxel docetaxel Injectable;Injection Sandoz Manufacturing Change or Addition
Hydromorphone Hydrochloride hydromorphone hydrochloride Injectable;Injection Hospira Inc Manufacturing Change or Addition
Neurontin gabapentin Capsule;Oral Pfizer Pharms Labeling Revision
Neurontin gabapentin Tablet;Oral Pfizer Pharms Labeling Revision
Neurontin gabapentin Solution;Oral Parke Davis Labeling Revision
Rifampin rifampin Injectable;Injection Emcure Pharms Ltd Approval
Tecfidera dimethyl fumarate Capsule, Delayed Release;Oral Biogen Idec Inc Manufacturing Change or Addition

 

August 16, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Actoplus Met metformin hydrochloride; pioglitazone hydrochloride Tablet;Oral Takeda Pharms Usa Labeling Revision

 

August 15, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Abilify Maintena Kit aripiprazole For Suspension, Extended Release;Intramuscular Otsuka Pharm Co Ltd Manufacturing Change or Addition
Absorica isotretinoin Capsule;Oral Ranbaxy Manufacturing Change or Addition
Dextrose 5% and Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira Manufacturing Change or Addition
Iclusig ponatinib hydrochloride Tablet;Oral Ariad Manufacturing Change or Addition
Lactated Ringer's In Plastic Container calcium chloride; potassium chloride; sodium chloride; sodium lactate Solution;Irrigation Hospira Manufacturing Change or Addition
Metoclopramide Hydrochloride metoclopramide hydrochloride Tablet, Orally Disintegrating;Oral Novel Labs Inc Approval
Olanzapine olanzapine Tablet;Oral Macleods Pharms Ltd Approval
Piperacillin and Tazobactam piperacillin;tazobactam Injectable;Injection Agila Speclts Approval
Plegridy peginterferon beta-1a Injectable;Injection Biogen Idec Inc Approval
Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Container calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira Manufacturing Change or Addition

 

August 14, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Avastin bevacizumab Vial; Intravenous Genentech Efficacy Supplement with Clinical Data to Support
Colcrys colchicine Tablet;Oral Takeda Pharms Usa Labeling Revision
Combivent Respimat albuterol sulfate; ipratropium bromide Spray, Metered;Inhalation Boehringer Ingelheim Manufacturing Change or Addition
Commit nicotine polacrilex Troche/Lozenge;Oral Glaxosmithkline Cons Labeling Revision
Decitabine decitabine Powder;Intravenous Sun Pharma Global Manufacturing Change or Addition
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate efavirenz;lamivudine;tenofovir disoproxil fumarate Tablet;Oral Macleods Pharms Ltd Tentative Approval
Lotensin Hct benazepril hydrochloride; hydrochlorothiazide Tablet;Oral Us Pharms Holdings I Manufacturing Change or Addition
Metopirone metyrapone Capsule;Oral Hra Pharma Manufacturing Change or Addition
Metopirone metyrapone Tablet;Oral Hra Pharma Manufacturing Change or Addition
Migranal dihydroergotamine mesylate Spray, Metered;Nasal Valeant Manufacturing Change or Addition
Pegintron peginterferon alfa-2b Syringe Schering Labeling Revision
Pegintron peginterferon alfa-2b Vial Schering Labeling Revision
Pradaxa dabigatran etexilate mesylate Capsule;Oral Boehringer Ingelheim Labeling Revision
Sustiva efavirenz Capsule;Oral Bristol Myers Squibb Manufacturing Change or Addition
Sustiva efavirenz Tablet;Oral Bristol Myers Squibb Manufacturing Change or Addition
Sylatron peginterferon alfa-2b Vial Schering Labeling Revision
Vascepa icosapent ethyl Capsule;Oral Amarin Pharms Manufacturing Change or Addition

 

August 13, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Belsomra suvorexant Tablet; Oral Merck and Co Inc Approval
Depocyt cytarabine Injectable, Liposomal;Injection Pacira Pharms Inc Manufacturing Change or Addition
Diprolene betamethasone dipropionate Ointment, Augmented;Topical Merck Sharp Dohme Labeling Revision
Diprolene betamethasone dipropionate Lotion, Augmented;Topical Merck Sharp Dohme Labeling Revision
Diprolene Af betamethasone dipropionate Cream, Augmented;Topical Merck Sharp Dohme Labeling Revision
Etomidate etomidate Injectable;Injection Emcure Pharms Ltd Approval
Exparel bupivacaine Injectable, Liposomal;Injection Pacira Pharms Inc Manufacturing Change or Addition
Forteo teriparatide recombinant human Injectable;Subcutaneous Lilly Manufacturing Change or Addition
Mekinist trametinib dimethyl sulfoxide Tablet;Oral Glaxosmithkline Llc Manufacturing Change or Addition
Navelbine vinorelbine tartrate Injectable;Injection Pierre Fabre Manufacturing Change or Addition
Neuraceq florbetaben f-18 Solution;Intravenous Piramal Imaging Manufacturing Change or Addition
Nilandron nilutamide Tablet;Oral Covis Pharma Sarl Manufacturing Change or Addition
Prometrium progesterone Capsule;Oral Abbvie Inc Manufacturing Change or Addition
Toviaz fesoterodine fumarate Tablet, Extended Release;Oral Pfizer Manufacturing Change or Addition
Zyban bupropion hydrochloride Tablet, Extended Release;Oral Glaxosmithkline Labeling Revision

 

August 12, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Bexarotene bexarotene Capsule;Oral Banner Pharmacaps Approval
Byetta exenatide synthetic Injectable;Subcutaneous Astrazeneca Ab Manufacturing Change or Addition
Coartem artemether; lumefantrine Tablet;Oral Novartis Manufacturing Change or Addition
Eliquis apixaban Tablet;Oral Bristol Myers Squibb Labeling Revision
Emend aprepitant Capsule;Oral Merck Labeling Revision
Emend fosaprepitant dimeglumine Powder;Intravenous Merck and Co Inc Labeling Revision
Estring estradiol Insert, Extended Release;Vaginal Pharmacia and Upjohn Labeling Revision
Femtrace estradiol acetate Tablet;Oral Warner Chilcott Llc Labeling Revision
Lastacaft alcaftadine Solution/Drops;Ophthalmic Allergan Manufacturing Change or Addition
Mobic meloxicam Suspension;Oral Boehringer Ingelheim Manufacturing Change or Addition
Nutrilipid 10% soybean oil Injectable;Injection B Braun Manufacturing Change or Addition
Nutrilipid 20% soybean oil Injectable;Injection B Braun Manufacturing Change or Addition
Rayos prednisone Tablet, Delayed Release;Oral Horizon Pharma Manufacturing Change or Addition
Ribavirin ribavirin Tablet;Oral Sandoz Inc Approval
Rituxan rituximab Vial Genentech Labeling Revision
Robaxin methocarbamol Injectable;Injection Hikma Maple Manufacturing Change or Addition
Suboxone buprenorphine hydrochloride; naloxone hydrochloride Film;Sublingual Reckitt Benckiser Manufacturing Change or Addition
Tranexamic Acid tranexamic acid Injectable;Injection Emcure Pharms Ltd Approval
Vimpat lacosamide Tablet;Oral Ucb Inc Labeling Revision
Vimpat lacosamide Solution;Intravenous Ucb Inc Labeling Revision
Vimpat lacosamide Solution;Oral Ucb Inc Labeling Revision

 

August 11, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Alimta pemetrexed disodium Injectable;Iv (Infusion) Lilly Manufacturing Change or Addition
Concerta methylphenidate hydrochloride Tablet, Extended Release;Oral Janssen Pharms Manufacturing Change or Addition
Gemzar gemcitabine hydrochloride Injectable;Injection Lilly Manufacturing Change or Addition
Glucagon glucagon recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Gonal-F follitropin alfa/beta Injectable;Subcutaneous Emd Serono Manufacturing Change or Addition
Gonal-F follitropin alfa/beta Injectable;Subcutaneous Emd Serono Manufacturing Change or Addition
Gonal-F Rff follitropin alfa/beta Injectable;Subcutaneous Emd Serono Manufacturing Change or Addition
Humatrope somatropin recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Intron A interferon alfa-2b Vial Schering Labeling Revision
Namenda memantine hydrochloride Solution;Oral Forest Labs Labeling Revision
Pegintron peginterferon alfa-2b Syringe Schering Labeling Revision
Pegintron peginterferon alfa-2b Vial Schering Labeling Revision
Quinidine Gluconate quinidine gluconate Injectable;Injection Lilly Manufacturing Change or Addition
Saizen somatropin recombinant Injectable;Injection Emd Serono Manufacturing Change or Addition
Serostim somatropin recombinant Injectable;Injection Emd Serono Manufacturing Change or Addition
Serostim Lq somatropin recombinant Injectable;Subcutaneous Emd Serono Manufacturing Change or Addition
Sylatron peginterferon alfa-2b Vial Schering Labeling Revision
Zorvolex diclofenac Capsule;Oral Iroko Pharms Llc Manufacturing Change or Addition
Zyprexa olanzapine Injectable;Intramuscular Lilly Manufacturing Change or Addition

 

August 8, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Capecitabine capecitabine Tablet;Oral Mylan Pharms Inc Approval
Farxiga dapagliflozin Tablet;Oral Astrazeneca Ab Labeling Revision
Invokamet canagliflozin and metformin hydrochloride Tablet; Oral Janssen Pharms Approval
Juxtapid lomitapide mesylate Capsule;Oral Aegerion Labeling Revision
Silenor doxepin hydrochloride Tablet;Oral Pernix Theraps Llc Manufacturing Change or Addition
Velcade bortezomib Injectable;Intravenous, Subcutaneous Millennium Pharms Efficacy Supplement with Clinical Data to Support
Videx didanosine For Solution;Oral Bristol Myers Squibb Labeling Revision
Xanax alprazolam Tablet;Oral Pharmacia and Upjohn Manufacturing Change or Addition

 

August 7, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Angiomax bivalirudin Injectable;Intravenous Medicines Co Manufacturing Change or Addition
Axert almotriptan malate Tablet;Oral Janssen Pharms Labeling Revision
Delflex W/ Dextrose 1.5% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;Intraperitoneal Fresenius Medcl Manufacturing Change or Addition
Humira adalimumab Syringe Abbvie Inc Manufacturing Change or Addition
Humira adalimumab Vial Abbvie Inc Manufacturing Change or Addition
Norpramin desipramine hydrochloride Tablet;Oral Sanofi Aventis Us Manufacturing Change or Addition
Optimark gadoversetamide Injectable;Injection Mallinckrodt Labeling Revision
Optimark gadoversetamide Injectable;Injection Mallinckrodt Labeling Revision
Optimark In Plastic Container gadoversetamide Injectable;Injection Mallinckrodt Labeling Revision

 

August 6, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Fludeoxyglucose F18 fludeoxyglucose Injectable;Injection Univ Iowa Hosps Approval
Orbactiv oritavancin diphosphate Powder, For Injection Solution, Lyophilized Powder Medicines Co Approval
Phentermine Hydrochloride phentermine hydrochloride Tablet;Oral Aurolife Pharma Llc Approval

 

August 5, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Bimatoprost bimatoprost Solution; Ophthalmic Sandoz Inc Tentative Approval
Loestrin Fe 1.5/30 ethinyl estradiol; norethindrone acetate Tablet;Oral-28 Warner Chilcott Llc Manufacturing Change or Addition
Tenofovir Disoproxil Fumarate tenofovir disoproxil fumarate Tablet;Oral Macleods Pharma Tentative Approval
Vincristine Sulfate Pfs vincristine sulfate Injectable;Injection Hospira Labeling Revision
Zosyn piperacillin sodium; tazobactam sodium Injectable;Injection Wyeth Pharms Inc Manufacturing Change or Addition

 

August 4, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Ketorolac Tromethamine ketorolac tromethamine Injectable;Injection Agila Speclts Approval
Myfortic mycophenolic acid Tablet, Delayed Release;Oral Novartis Manufacturing Change or Addition
Sirturo bedaquiline fumarate Tablet;Oral Janssen Therap Manufacturing Change or Addition

 

August 3, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Miralax polyethylene glycol 3350 For Solution;Oral Schering Plough Manufacturing Change or Addition

 

August 1, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Differin adapalene Cream;Topical Galderma Labs Lp Manufacturing Change or Addition
Epiduo adapalene; benzoyl peroxide Gel;Topical Galderma Labs Lp Manufacturing Change or Addition
Halaven eribulin mesylate Solution;Intravenous Eisai Inc Labeling Revision
Inlyta axitinib Tablet;Oral Pfizer Labeling Revision
Jardiance empagliflozin Tablet;Oral Boehringer Ingelheim Approval
Keppra Xr levetiracetam Tablet, Extended Release;Oral Ucb Inc Efficacy Supplement with Clinical Data to Support
Loestrin Fe 1/20 ethinyl estradiol; norethindrone acetate Tablet;Oral-28 Warner Chilcott Manufacturing Change or Addition
Lumizyme alglucosidase alfa Powder; Iv (Infusion) Genzyme Efficacy Supplement with Clinical Data to Support
Metronidazole In Plastic Container metronidazole Injectable;Injection Hospira Manufacturing Change or Addition
Oxycodone Hydrochloride oxycodone hydrochloride Capsule;Oral Lannett Holdings Inc Approval
Sterile Water For Injection In Plastic Container sterile water for injection Liquid;N/A Hospira Manufacturing Change or Addition
Tyvaso treprostinil Solution;Inhalation United Therap Labeling Revision

 

July 31, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adrenalin epinephrine Injectable;Intramuscular, Intraocular, Subcutaneous Par Sterile Products Manufacturing Change or Addition
Estradiol estradiol Film, Extended Release; Transdermal Novartis Labeling Revision
Farxiga dapagliflozin Tablet;Oral Astrazeneca Ab Manufacturing Change or Addition
Fortesta testosterone Gel, Metered;Transdermal Endo Pharms Supplement
Gilotrif afatinib dimaleate Tablet;Oral Boehringer Ingelheim Manufacturing Change or Addition
Hectorol doxercalciferol Injectable;Injection Genzyme Corp Manufacturing Change or Addition
Humalog insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Kwikpen insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Pen insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Loestrin Fe 1/20 ethinyl estradiol; norethindrone acetate Tablet;Oral-28 Warner Chilcott Manufacturing Change or Addition
Megace Es megestrol acetate Suspension;Oral Par Pharm Manufacturing Change or Addition
Pegintron peginterferon alfa-2b Syringe Schering Labeling Revision
Pegintron peginterferon alfa-2b Vial Schering Labeling Revision
Somavert pegvisomant Injectable;Subcutaneous Pharmacia and Upjohn Manufacturing Change or Addition
Striverdi Respimat olodaterol respimat Spray;Metered Boehringer Ingelheim Approval
Sylatron peginterferon alfa-2b Vial Schering Labeling Revision
Victoza liraglutide recombinant Solution;Subcutaneous Novo Nordisk Inc Labeling Revision
Vivelle-Dot estradiol Film, Extended Release;Transdermal Novartis Labeling Revision
Zanosar streptozocin Injectable;Injection Teva Pharms Usa Manufacturing Change or Addition
Zelapar selegiline hydrochloride Tablet, Orally Disintegrating;Oral Valeant Pharm Intl Labeling Revision

 

July 30, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Absorica isotretinoin Capsule;Oral Ranbaxy Labeling Revision
Amoxil amoxicillin For Suspension;Oral Dr Reddys Labs Inc Manufacturing Change or Addition
Belviq lorcaserin hydrochloride Tablet;Oral Eisai Inc Manufacturing Change or Addition
Canasa mesalamine Suppository;Rectal Forest Labs Inc Manufacturing Change or Addition
Diclegis doxylamine succinate; pyridoxine hydrochloride Tablet, Delayed Release;Oral Duchesnay Manufacturing Change or Addition
Excedrin (Migraine) acetaminophen; aspirin; caffeine Tablet;Oral Novartis Manufacturing Change or Addition
Humatrope somatropin recombinant Injectable;Injection Lilly Labeling Revision
Iclusig ponatinib hydrochloride Tablet;Oral Ariad Manufacturing Change or Addition
Jentadueto linagliptin; metformin hydrochloride Tablet;Oral Boehringer Ingelheim Efficacy Supplement with Clinical Data to Support
Quelicin succinylcholine chloride Injectable;Injection Hospira Manufacturing Change or Addition
Quelicin Preservative Free succinylcholine chloride Injectable;Injection Hospira Manufacturing Change or Addition

 

July 29, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Dextromethorphan Hydrobromide and Quinidine Sulfate dextromethorphan hydrobromide;quinidine sulfate Capsule;Oral Par Pharm Inc Tentative Approval
Epinephrine epinephrine Injectable;Injection Belcher Pharms Approval
Kalydeco ivacaftor Tablet;Oral Vertex Pharms Manufacturing Change or Addition
Korlym mifepristone Tablet;Oral Corcept Therap Manufacturing Change or Addition
Natrecor nesiritide recombinant For Solution;Intravenous Scios Llc Manufacturing Change or Addition
Prandimet metformin hydrochloride; repaglinide Tablet;Oral Novo Nordisk Inc Manufacturing Change or Addition
Viokace pancrelipase (amylase;lipase;protease) Tablet;Oral Forest Labs Inc Manufacturing Change or Addition

 

July 28, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Anafranil clomipramine hydrochloride Capsule;Oral Mallinckrodt Llc Labeling Revision
Aromasin exemestane Tablet;Oral Pharmacia and Upjohn Manufacturing Change or Addition
Caduet amlodipine besylate; atorvastatin calcium Tablet;Oral Pfizer Manufacturing Change or Addition
Cardura doxazosin mesylate Tablet;Oral Pfizer Manufacturing Change or Addition
Cardura Xl doxazosin mesylate Tablet, Extended Release;Oral Pfizer Manufacturing Change or Addition
Celebrex celecoxib Capsule;Oral Gd Searle Manufacturing Change or Addition
Chantix varenicline tartrate Tablet;Oral Pfizer Inc Manufacturing Change or Addition
Detrol tolterodine tartrate Tablet;Oral Pharmacia and Upjohn Manufacturing Change or Addition
Detrol La tolterodine tartrate Capsule, Extended Release;Oral Pharmacia and Upjohn Manufacturing Change or Addition
Diflucan fluconazole Tablet;Oral Pfizer Manufacturing Change or Addition
Diflucan fluconazole For Suspension;Oral Pfizer Manufacturing Change or Addition
Diflucan In Dextrose 5% In Plastic Container fluconazole Injectable;Injection Pfizer Manufacturing Change or Addition
Diflucan In Sodium Chloride 0.9% fluconazole Injectable;Injection Pfizer Manufacturing Change or Addition
Diflucan In Sodium Chloride 0.9% In Plastic Container fluconazole Injectable;Injection Pfizer Manufacturing Change or Addition
Exemestane exemestane Tablet;Oral Eirgen Pharma Ltd Approval
Imbruvica ibrutinib Capsule;Oral Pharmacyclics Inc Efficacy Supplement with Clinical Data to Support
Korlym mifepristone Tablet;Oral Corcept Therap Manufacturing Change or Addition
Minipress prazosin hydrochloride Capsule;Oral Pfizer Manufacturing Change or Addition
Norvasc amlodipine besylate Tablet;Oral Pfizer Manufacturing Change or Addition
Otezla apremilast Tablet;Oral Celgene Corp Manufacturing Change or Addition
Pamelor nortriptyline hydrochloride Solution;Oral Mallinckrodt Inc Labeling Revision
Pamelor nortriptyline hydrochloride Capsule;Oral Mallinckrodt Llc Labeling Revision
Taclonex betamethasone dipropionate; calcipotriene hydrate Ointment;Topical Leo Pharma As Labeling Revision
Taclonex betamethasone dipropionate; calcipotriene hydrate Suspension;Topical Leo Pharma As Labeling Revision
Technescan Mag3 technetium tc-99m mertiatide kit Injectable;Injection Mallinckrodt Manufacturing Change or Addition
Tofranil-Pm imipramine pamoate Capsule;Oral Mallinckrodt Inc Labeling Revision
Vascepa icosapent ethyl Capsule;Oral Amarin Pharms Manufacturing Change or Addition
Victrelis boceprevir Capsule;Oral Merck Sharp Dohme Labeling Revision
Zyvox linezolid Tablet;Oral Pharmacia and Upjohn Manufacturing Change or Addition
Zyvox linezolid Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Zyvox linezolid For Suspension;Oral Pharmacia and Upjohn Manufacturing Change or Addition

 

July 25, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Acticlate doxycycline hyclate Tablet;Oral Aqua Pharms Approval
Adrenaclick epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Labeling Revision
Alinia nitazoxanide For Suspension;Oral Romark Manufacturing Change or Addition
Apokyn apomorphine hydrochloride Injectable;Subcutaneous Us Worldmeds Labeling Revision
Azactam In Plastic Container aztreonam Injectable;Injection Bristol Myers Squibb Manufacturing Change or Addition
Biaxin clarithromycin Tablet;Oral Abbvie Labeling Revision
Biaxin clarithromycin For Suspension;Oral Abbvie Labeling Revision
Biaxin Xl clarithromycin Tablet, Extended Release;Oral Abbvie Labeling Revision
Children's Claritin loratadine Tablet, Chewable;Oral Schering Plough Labeling Revision
Habitrol nicotine Film, Extended Release; Transdermal Novartis Labeling Revision
Habitrol nicotine Film, Extended Release;Transdermal Novartis Labeling Revision
Jakafi ruxolitinib phosphate Tablet;Oral Incyte Corp Efficacy Supplement with Clinical Data to Support
Lastacaft alcaftadine Solution/Drops;Ophthalmic Allergan Manufacturing Change or Addition
Mestinon pyridostigmine bromide Tablet, Extended Release;Oral Valeant Pharms Llc Manufacturing Change or Addition
Pradaxa dabigatran etexilate mesylate Capsule;Oral Boehringer Ingelheim Manufacturing Change or Addition
Prevantics Maxi Swabstick chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Prevantics Swab chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Prevantics Swabstick chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Twinject 0.15 epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Labeling Revision
Twinject 0.3 epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Labeling Revision

 

July 24, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adderall Xr 10 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 15 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 20 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 30 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Adderall Xr 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate Capsule, Extended Release;Oral Shire Labeling Revision
Crixivan indinavir sulfate Capsule;Oral Merck Sharp Dohme Labeling Revision
Fortical calcitonin salmon recombinant Spray, Metered;Nasal Upsher Smith Manufacturing Change or Addition

 

July 23, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cardene nicardipine hydrochloride Injectable;Injection Chiesi Usa Inc Labeling Revision
Cardene In 0.83% Sodium Chloride In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Labeling Revision
Cardene In 0.86% Sodium Chloride In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Labeling Revision
Cardene In 4.8% Dextrose In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Labeling Revision
Cardene In 5.0% Dextrose In Plastic Container nicardipine hydrochloride Injectable;Intravenous Chiesi Usa Inc Labeling Revision
Edarbi azilsartan kamedoxomil Tablet;Oral Arbor Pharms Ireland Labeling Revision
Edarbyclor azilsartan kamedoxomil; chlorthalidone Tablet;Oral Arbor Pharms Ireland Labeling Revision
Flonase Allergy Relief fluticasone propionate Spray;Metered Glaxosmithkline Cons Approval
Hydrochlorothiazide hydrochlorothiazide Tablet;Oral Sciegen Pharms Inc Approval
Targiniq Er oxycodone hydrochloride;naloxone hydrochloride Tablet, Extended Release;Oral Purdue Pharma Lp Approval
Terazol 3 terconazole Suppository;Vaginal Janssen Pharms Labeling Revision
Terazol 3 terconazole Cream;Vaginal Janssen Pharms Labeling Revision
Terazol 7 terconazole Cream;Vaginal Janssen Pharms Labeling Revision
Testosterone testosterone Gel;Transdermal Teva Pharms Labeling Revision
Zydelig idelalisib Tablet;Oral Gilead Sciences Inc Approval
Zydelig idelalisib Tablet;Oral Gilead Sciences Inc Approval

 

July 22, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Claritin Hives Relief Reditab loratadine Tablet, Orally Disintegrating;Oral Schering Plough Labeling Revision
Claritin Reditabs loratadine Tablet, Orally Disintegrating;Oral Schering Plough Labeling Revision
Claritin Reditabs loratadine Tablet, Orally Disintegrating;Oral Schering Plough Labeling Revision
Cytoxan cyclophosphamide Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Cytoxan (Lyophilized) cyclophosphamide Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Desonate desonide Gel;Topical Bayer Hlthcare Labeling Revision
Lotensin Hct benazepril hydrochloride; hydrochlorothiazide Tablet;Oral Us Pharms Holdings I Manufacturing Change or Addition
Lyophilized Cytoxan cyclophosphamide Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Otezla apremilast Tablet;Oral Celgene Corp Manufacturing Change or Addition
Prohance Multipack gadoteridol Injectable;Injection Bracco Labeling Revision
Ryanodex dantrolene sodium Suspension;Injectable Eagle Pharms Approval
Solu-Cortef hydrocortisone sodium succinate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Solu-Medrol methylprednisolone sodium succinate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Tacrolimus tacrolimus Capsule;Oral Strides Arcolab Ltd Approval
Teveten eprosartan mesylate Tablet;Oral Abbvie Labeling Revision
Teveten Hct eprosartan mesylate; hydrochlorothiazide Tablet;Oral Abbvie Labeling Revision
Xeloda capecitabine Tablet;Oral Hoffmann La Roche Manufacturing Change or Addition
Zoledronic Acid zoledronic acid Injectable;Injection Sun Pharma Global Tentative Approval

 

July 21, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride Syrup;Oral Vintage Pharms Approval
Fiorinal aspirin; butalbital; caffeine Capsule;Oral Watson Labs Inc Manufacturing Change or Addition
Fiorinal aspirin; butalbital; caffeine Tablet;Oral Watson Labs Inc Manufacturing Change or Addition
Pennsaid diclofenac sodium Solution;Topical Mallinckrodt Inc Manufacturing Change or Addition
Qvar 40 beclomethasone dipropionate Aerosol, Metered;Inhalation Teva Branded Pharm Labeling Revision
Qvar 80 beclomethasone dipropionate Aerosol, Metered;Inhalation Teva Branded Pharm Labeling Revision

 

July 20, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Flomax tamsulosin hydrochloride Capsule;Oral Boehringer Ingelheim Labeling Revision