Drugs

New and Generic Drug Approvals

August 30, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Erelzi etanercept-szzs Injectable;Injection Sandoz Inc Approval

 

August 29, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adalat Cc nifedipine Tablet, Extended Release;Oral Alvogen Manufacturing Change or Addition
Children's Motrin ibuprofen Suspension/Drops;Oral J and J Consumer Inc Labeling Revision
Chloraprep One-Step chlorhexidine gluconate; isopropyl alcohol Sponge;Topical Becton Dickinson Co Manufacturing Change or Addition
Chloraprep One-Step Frepp chlorhexidine gluconate; isopropyl alcohol Sponge;Topical Becton Dickinson Co Manufacturing Change or Addition
Chloraprep With Tint chlorhexidine gluconate; isopropyl alcohol Sponge;Topical Becton Dickinson Co Manufacturing Change or Addition
Chorionic Gonadotropin gonadotropin, chorionic Injectable;Injection Ferring Manufacturing Change or Addition
Cyklokapron tranexamic acid Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Definity perflutren Injectable;Intravenous Lantheus Medcl Manufacturing Change or Addition
Depocyt cytarabine Injectable, Liposomal;Injection Pacira Pharms Inc Manufacturing Change or Addition
E-Z-Hd barium sulfate For Suspension;Oral Bracco Manufacturing Change or Addition
Edarbyclor azilsartan kamedoxomil; chlorthalidone Tablet;Oral Arbor Pharms Llc Manufacturing Change or Addition
Estradiol estradiol Film, Extended Release; Transdermal Novartis Manufacturing Change or Addition
Invega Sustenna paliperidone palmitate Suspension, Extended Release;Intramuscular Janssen Pharms Manufacturing Change or Addition
Klor-Con potassium chloride Tablet, Extended Release;Oral Upsher-Smith Labs Manufacturing Change or Addition
M.V.I. Pediatric ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; phytonadione; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e For Solution;Iv (Infusion) Hospira Manufacturing Change or Addition
Netspot gallium ga 68 dotatate Kit Advanced Accelerator Applications Usa Inc Manufacturing Change or Addition
Optimark gadoversetamide Injectable;Injection Liebel-Flarsheim Labeling Revision
Optimark gadoversetamide Injectable;Injection Liebel-Flarsheim Labeling Revision
Optimark In Plastic Container gadoversetamide Injectable;Injection Liebel-Flarsheim Labeling Revision
Perforomist formoterol fumarate Solution;Inhalation Mylan Speclt Manufacturing Change or Addition
Provocholine methacholine chloride For Solution;Inhalation Methapharm Manufacturing Change or Addition
Spiriva tiotropium bromide Powder;Inhalation Boehringer Ingelheim Manufacturing Change or Addition
Vivelle-Dot estradiol Film, Extended Release;Transdermal Novartis Manufacturing Change or Addition

 

August 26, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Azithromycin azithromycin Suspension;Oral Novel Labs Inc Tentative Approval
Cardene nicardipine hydrochloride Capsule;Oral Chiesi Usa Inc Labeling Revision
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
Cardene Sr nicardipine hydrochloride Capsule, Extended Release;Oral Chiesi Usa Inc Labeling Revision
Eletriptan Hydrobromide eletriptan hydrobromide Tablet;Oral Ajanta Pharma Ltd Tentative Approval
Hydrocodone Bitartrate hydrocodone bitartrate Capsule, Extended Release;Oral Actavis Labs Fl Inc Tentative Approval
Mycamine micafungin sodium Injectable; Injection Astellas Labeling Revision
Mycamine micafungin sodium Injectable;Iv (Infusion) Astellas Labeling Revision
Nitrostat nitroglycerin Tablet;Sublingual Pfizer Pharms Labeling Revision
Pristiq desvenlafaxine succinate Tablet, Extended Release;Oral Wyeth Pharms Inc Labeling Revision
Stivarga regorafenib Tablet;Oral Bayer Hlthcare Labeling Revision
Tylenol acetaminophen Tablet, Extended Release;Oral J and J Consumer Inc Labeling Revision
Visine-A naphazoline hydrochloride; pheniramine maleate Solution/Drops;Ophthalmic Johnson and Johnson Labeling Revision
Zantac 150 ranitidine hydrochloride Tablet;Oral Boehringer Ingelheim Labeling Revision

 

August 25, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Codeine Phosphate and Chlorpheniramine Maleate chlorpheniramine maleate; codeine phosphate Tablet, Extended Release;Oral Spriaso Llc Labeling Revision
Gleevec imatinib mesylate Tablet;Oral Novartis Efficacy Supplement with Clinical Data to Support
Gleevec imatinib mesylate Tablet;Oral Novartis Labeling Revision
Neuraceq florbetaben f-18 Solution;Intravenous Piramal Imaging Labeling Revision
Trivagizole 3 clotrimazole Cream;Vaginal Taro Labeling Revision
Xarelto rivaroxaban Tablet;Oral Janssen Pharms Labeling Revision

 

August 24, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Amoxicillin and Clavulanate Potassium amoxicillin; clavulanate potassium Tablet;Oral Hikma Pharms Approval
Calan verapamil hydrochloride Tablet;Oral Gd Searle Llc Labeling Revision
Calan verapamil hydrochloride Injectable;Injection Gd Searle Llc Labeling Revision
Calan Sr verapamil hydrochloride Tablet, Extended Release;Oral Pfizer Labeling Revision
Codeine Sulfate codeine sulfate Solution;Oral Roxane Manufacturing Change or Addition
Covera-Hs verapamil hydrochloride Tablet, Extended Release;Oral Gd Searle Llc Labeling Revision
Ethacrynate Sodium ethacrynate sodium Injectable;Injection Mylan Institutional Approval
Fortamet metformin hydrochloride Tablet, Extended Release;Oral Andrx Labs Llc Manufacturing Change or Addition
Pacitaxel paclitaxel Injectable;Injection Gland Pharma Ltd Approval
Paroxetine paroxetine Tablet, Extended Release;Oral Lupin Ltd Tentative Approval
Rhinocort budesonide Spray, Metered;Nasal Astrazeneca Pharms Labeling Revision
Rhinocort Allergy budesonide Spray, Metered;Nasal Astrazeneca Pharms Labeling Revision
Trospium Chloride trospium chloride Tablet;Oral Invagen Pharms Approval
Xarelto rivaroxaban Tablet; Oral Janssen Pharms Manufacturing Change or Addition

 

August 23, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Lamisil terbinafine hydrochloride Tablet;Oral Novartis Labeling Revision
Lamisil terbinafine hydrochloride Granule;Oral Novartis Labeling Revision
Ranitidine Hydrochloride ranitidine hydrochloride Tablet;Oral Strides Pharma Approval
Vidaza azacitidine Injectable;Intravenous, Subcutaneous Celgene Labeling Revision
Zyrtec Allergy cetirizine hydrochloride Tablet, Orally Disintegrating;Oral J and J Consumer Inc Labeling Revision

 

August 22, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Banzel rufinamide Tablet;Oral Eisai Inc Manufacturing Change or Addition
Linezolid linezolid Tablet;Oral Novel Labs Inc Approval
Loestrin 24 Fe ethinyl estradiol; norethindrone acetate Tablet;Oral Warner Chilcott Labeling Revision
Melphalan Hydrochloride melphalan hydrochloride Injectable;Injection Par Sterile Products Approval
Movantik naloxegol oxalate Tablet;Oral Astrazeneca Pharms Labeling Revision
Nitroglycerin In Dextrose 5% nitroglycerin Injectable;Injection Baxter Hlthcare Labeling Revision
Palonosetron Hydrochloride palonosetron hydrochloride Injectable;Injection Exela Pharma Scs Llc Approval
Trecator ethionamide Tablet;Oral Wyeth Pharms Inc Labeling Revision
Xarelto rivaroxaban Tablet;Oral Janssen Pharms Manufacturing Change or Addition

 

August 21, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Omeprazole and Sodium Bicarbonate omeprazole; sodium bicarbonate Capsule;Oral Aurolife Pharma Llc Approval

Page Last Updated: 08/30/2016
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