Drugs

New and Generic Drug Approvals

September 18, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aloxi palonosetron hydrochloride Injectable;Intravenous Helsinn Hlthcare Labeling Revision
Aloxi palonosetron hydrochloride Capsule;Oral Helsinn Hlthcare Labeling Revision
Anzemet dolasetron mesylate Tablet;Oral Sanofi Aventis Us Labeling Revision
Anzemet dolasetron mesylate Injectable;Injection Sanofi Aventis Us Labeling Revision
Biltricide praziquantel Tablet;Oral Bayer Hlthcare Manufacturing Change or Addition
Cefazolin and Dextrose cefazolin sodium Injectable;Injection B Braun Efficacy Supplement with Clinical Data to Support
Cleocin Phosphate In Dextrose 5% In Plastic Container clindamycin phosphate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Halcion triazolam Tablet;Oral Pharmacia and Upjohn Labeling Revision
Hydralazine Hydrochloride hydralazine hydrochloride Tablet;Oral Cadila Pharms Ltd Approval
Megace Es megestrol acetate Suspension;Oral Par Pharm Labeling Revision
Ofloxacin ofloxacin Tablet;Oral Cadila Pharms Ltd Approval
Sancuso granisetron Film, Extended Release;Transdermal Prostrakan Inc Labeling Revision
Trulicity dulaglutide Injectable;Injection Eli Lilly and Co Approval
Vasostrict vasopressin Solution;Iv (Infusion) Par Sterile Products Manufacturing Change or Addition
Zofran ondansetron hydrochloride Injectable;Injection Glaxosmithkline Labeling Revision
Zofran ondansetron hydrochloride Tablet;Oral Glaxosmithkline Labeling Revision
Zofran ondansetron hydrochloride Solution;Oral Glaxosmithkline Labeling Revision
Zofran Odt ondansetron Tablet, Orally Disintegrating;Oral Glaxosmithkline Labeling Revision
Zofran Preservative Free ondansetron hydrochloride Injectable;Injection Glaxosmithkline Labeling Revision
Zuplenz ondansetron Film;Oral Galena Biopharma Inc Labeling Revision

 

September 17, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Amoxapine amoxapine Tablet;Oral Watson Labs Labeling Revision
Citalopram Hydrobromide citalopram hydrobromide Solution;Oral Roxane Labeling Revision
Daliresp roflumilast Tablet;Oral Forest Res Inst Inc Manufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Docetaxel docetaxel Injectable;Injection Actavis Inc Labeling Revision
Lactated Ringer's In Plastic Container calcium chloride; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira 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
Sodium Chloride 0.45% In Plastic Container sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Stendra avanafil Tablet;Oral Vivus Efficacy Supplement with Clinical Data to Support
Tofranil imipramine hydrochloride Tablet;Oral Mallinckrodt Inc Labeling Revision
Venlafaxine Hydrochloride venlafaxine hydrochloride Tablet;Oral Teva Labeling Revision
Vivactil protriptyline hydrochloride Tablet;Oral Odyssey Pharms Labeling Revision

 

September 16, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Ambisome amphotericin b Injectable, Liposomal;Injection Astellas Manufacturing Change or Addition
Complera emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Labeling Revision
Fortical calcitonin salmon recombinant Spray, Metered;Nasal Upsher Smith Manufacturing Change or Addition
Movantik naloxegol Tablet, Tablet;Oral Astrazeneca Pharms Approval
Tegretol carbamazepine Tablet;Oral Novartis Labeling Revision
Tegretol carbamazepine Tablet, Chewable;Oral Novartis Labeling Revision
Tegretol carbamazepine Suspension;Oral Novartis Labeling Revision
Tegretol-Xr carbamazepine Tablet, Extended Release;Oral Novartis Labeling Revision
Tobramycin Sulfate tobramycin sulfate Injectable;Injection Akorn Approval
Tobramycin Sulfate tobramycin sulfate Injectable;Injection Xellia Pharms Aps Approval
Varithena polidocanol Solution;Intravenous Provensis Manufacturing Change or Addition

 

September 15, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adenosine adenosine Injectable; Injection Emcure Pharms Ltd Approval
Aminosyn Ii 10% In Plastic Container amino acids Injectable;Injection Hospira Manufacturing Change or Addition
Amoxicillin amoxicillin Suspension;Oral Aurobindo Pharma Ltd Approval
Budesonide budesonide Solution;Topical Foam Salix Pharms Tentative Approval
Centany mupirocin Ointment;Topical Perrigo New York Manufacturing Change or Addition
Clinimix 2.75/10 Sulfite Free In Dextrose 10% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 2.75/25 Sulfite Free In Dextrose 25% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 2.75/5 Sulfite Free In Dextrose 5% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 4.25/10 Sulfite Free In Dextrose 10% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 4.25/20 Sulfite Free In Dextrose 20% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 4.25/25 Sulfite Free In Dextrose 25% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 4.25/5 Sulfite Free In Dextrose 5% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 5/10 Sulfite Free In Dextrose 10% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 5/15 Sulfite Free In Dextrose 15% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 5/20 Sulfite Free In Dextrose 20% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 5/25 Sulfite Free In Dextrose 25% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix 5/35 Sulfite Free In Dextrose 35% In Plastic Container amino acids; dextrose Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 2.75/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 2.75/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 2.75/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 4.25/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 4.25/20 Sulfite-Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 4.25/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 4.25/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 5/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 5/15 Sulfite-Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 5/20 Sulfite-Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 5/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clinimix E 5/35 Sulfite-Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Container amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Clopidogrel clopidogrel Tablet;Oral Sciegen Pharms Inc Approval
Glipizide glipizide Tablet, Extended Release;Oral Zydus Pharms Usa Inc Tentative Approval
Membraneblue trypan blue Solution;Ophthalmic Dorc Labeling Revision
Methylin methylphenidate hydrochloride Solution;Oral Mallinckrodt Manufacturing Change or Addition
Methylin methylphenidate hydrochloride Tablet, Chewable;Oral Mallinckrodt Manufacturing Change or Addition
Setlakin ethinyl estradiol; levonorgestrel Tablet;Oral Novast Labs Ltd Approval
Travasol 10% In Plastic Container amino acids Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Travasol 5.5% In Plastic Container amino acids Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Travasol 8.5% In Plastic Container amino acids Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition

 

September 12, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Advil Liqui-Gels ibuprofen Capsule;Oral Pfizer Manufacturing Change or Addition
Advil Migraine Liqui-Gels ibuprofen Capsule;Oral Pfizer Manufacturing Change or Addition
Afinitor everolimus Tablet;Oral Novartis Manufacturing Change or Addition
Allegra Allergy fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Labeling Revision
Allegra Hives fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Labeling Revision
Amlodipine and Valsartan amlodipine;valsartan Tablet;Oral Torrent Pharms Ltd Tentative Approval
An-Sulfur Colloid technetium tc-99m sulfur colloid kit Solution;Injection, Oral Pharmalucence Manufacturing Change or Addition
Children's Allegra Allergy fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Labeling Revision
Children's Allegra Hives fexofenadine hydrochloride Tablet;Oral Sanofi Aventis Us Labeling Revision
Clindamycin Phosphate and Benzoyl Peroxide benzoyl peroxide; clindamycin phosphate Gel;Topical Mylan Pharms Inc Manufacturing Change or Addition
Daptomycin daptomycin Injectable;Injection Hospira Inc Approval
Emtricitabine;Tenofovir Disoproxil Fumarate;Nevirapine emtricitabine;tenofovir disoproxil fumarate;nevirapine Tablet;Oral Mylan Labs Ltd Tentative Approval
Forteo teriparatide recombinant human Injectable;Subcutaneous Lilly Manufacturing Change or Addition
Glycine 1.5% In Plastic Container glycine Solution;Irrigation B Braun 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 Mix 50/50 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 50/50 Kwikpen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 50/50 Pen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/25 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/25 Kwikpen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/25 Pen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Pen insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humatrope somatropin recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humulin 70/30 insulin recombinant human; insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin 70/30 Pen insulin recombinant human; insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin N insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Mycophenolate Mofetil mycophenolate mofetil Capsule;Oral Roxane Manufacturing Change or Addition
Mycophenolate Mofetil mycophenolate mofetil Tablet;Oral Roxane Manufacturing Change or Addition
Naprelan naproxen sodium Tablet, Extended Release;Oral Almatica Pharma Inc Manufacturing Change or Addition
Pomalyst pomalidomide Capsule;Oral Celgene Labeling Revision
Revlimid lenalidomide Capsule;Oral Celgene Labeling Revision
Thalomid thalidomide Capsule;Oral Celgene Supplement
Vibra-Tabs doxycycline hyclate Tablet;Oral Pfizer Labeling Revision
Vibramycin doxycycline For Suspension;Oral Pfizer Labeling Revision
Vibramycin doxycycline hyclate Capsule;Oral Pfizer Labeling Revision
Vibramycin doxycycline calcium Suspension;Oral Pfizer Labeling Revision
Zoloft sertraline hydrochloride Tablet;Oral Pfizer Labeling Revision
Zoloft sertraline hydrochloride Concentrate;Oral Pfizer Labeling Revision

 

September 11, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Argatroban In Sodium Chloride argatroban Injectable;Iv (Infusion) Sandoz Manufacturing Change or Addition
Dorzolamide Hydrochloride dorzolamide hydrochloride Solution;Ophthalmic Watson Labs Inc Approval
Hectorol doxercalciferol Injectable;Injection Genzyme Corp Manufacturing Change or Addition
Levalbuterol Hydrochloride levalbuterol hydrochloride Solution;Inhalation Teva Parenteral Approval
Micronor norethindrone Tablet;Oral-28 Janssen Pharms Manufacturing Change or Addition
Modicon 28 ethinyl estradiol; norethindrone Tablet;Oral-28 Janssen Pharms Manufacturing Change or Addition
Montelukast Sodium montelukast sodium Tablet;Oral Macleods Pharms Ltd Approval
Opcicon One-Step levonorgestrel Tablet;Oral Sun Pharm Inds Approval
Ortho-Novum 1/35-28 ethinyl estradiol; norethindrone Tablet;Oral-28 Janssen Pharms Manufacturing Change or Addition
Ortho-Novum 7/7/7-21 ethinyl estradiol; norethindrone Tablet;Oral-21 Janssen Pharms Manufacturing Change or Addition
Ortho-Novum 7/7/7-28 ethinyl estradiol; norethindrone Tablet;Oral-28 Janssen Pharms Manufacturing Change or Addition

 

September 10, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Contrave naltrexone hydrochloride;bupropion hydrochloride Tablet, Extended Release;Oral Orexigen Therapeutics Inc Approval
Emsam selegiline Film, Extended Release;Transdermal Somerset Efficacy Supplement with Clinical Data to Support
Emsam selegiline Film, Extended Release;Transdermal Somerset Labeling Revision
Emsam selegiline System; Transdermal Somerset Approval
Famciclovir famciclovir Tablet;Oral Hetero Labs Ltd V Approval
Montelukast Sodium montelukast sodium Tablet;Oral Hetero Drugs Ltd Approval
Mucinex guaifenesin Tablet, Extended Release;Oral Reckitt Benckiser Manufacturing Change or Addition
Oxycodone Hydrochloride oxycodone hydrochloride Solution;Oral Lannett Holdings Inc Approval
Oxytocin oxytocin Injectable;Injection Fresenius Kabi Usa Manufacturing Change or Addition
Pantoprazole Sodium pantoprazole sodium Tablet, Delayed Release;Oral Hetero Labs Ltd V Approval
Xtandi enzalutamide Capsule;Oral Astellas Efficacy Supplement with Clinical Data to Support

 

September 9, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Argatroban In Sodium Chloride argatroban Injectable;Iv (Infusion) Eagle Pharms Labeling Revision
Iclusig ponatinib hydrochloride Tablet;Oral Ariad Manufacturing Change or Addition
Levocetirizine Dihydrochloride levocetirizine dihydrochloride Tablet;Oral Sciegen Pharms Inc Approval
Namenda Xr memantine hydrochloride Capsule, Extended Release;Oral Forest Labs Manufacturing Change or Addition
Tacrolimus tacrolimus Ointment;Topical Fougera Pharms Inc Approval
Ultratag technetium tc-99m red blood cell kit Injectable;Injection Mallinckrodt Manufacturing Change or Addition
Unithroid levothyroxine sodium Tablet;Oral Stevens J Manufacturing Change or Addition

 

September 8, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Boniva ibandronate sodium Injectable;Intravenous Roche Manufacturing Change or Addition
Brintellix vortioxetine hydrobromide Tablet;Oral Takeda Pharms Usa Manufacturing Change or Addition
Buprenorphine and Naloxone buprenorphine hydrocloride; naloxone hydrochloride Tablet;Sublingual Teva Pharms Usa Approval
Dextrose 10% In Plastic Container dextrose Injectable;Injection Hospira 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
Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Kalbitor ecallantide Injectable; Injection Dyax Corp. Labeling Revision
Lactated Ringer's In Plastic Container calcium chloride; potassium chloride; sodium chloride; sodium lactate Injectable;Injection Hospira Manufacturing Change or Addition
Nitrofurantoin nitrofurantoin Suspension;Oral Novel Labs Inc Approval
Normosol-M and Dextrose 5% In Plastic Container dextrose; magnesium acetate; potassium acetate; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Ondansetron Hydrochloride ondansetron hydrochloride Injectable;Injection Qilu Pharma Co Ltd 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 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride 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 15meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride 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 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% In Plastic Container dextrose; potassium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container potassium chloride; sodium chloride 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 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% In Plastic Container dextrose; potassium chloride 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 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% In Plastic Container dextrose; potassium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container potassium chloride; sodium chloride 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
Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Ringer's In Plastic Container calcium chloride; potassium chloride; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Container sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Container sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Sodium Chloride 3% In Plastic Container sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Sodium Chloride 5% In Plastic Container sodium chloride Injectable;Injection B Braun Manufacturing Change or Addition
Velcade bortezomib Injectable;Intravenous, Subcutaneous Millennium Pharms Manufacturing Change or Addition

 

September 6, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Solu-Cortef hydrocortisone sodium succinate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition

 

September 5, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Besivance besifloxacin hydrochloride Suspension/Drops;Ophthalmic Bausch and Lomb Manufacturing Change or Addition
Campath alemtuzumab Vial; Intravenous Ilex Pharmaceuticals Labeling Revision
Cerezyme imiglucerase Injectable;Injection Genzyme Manufacturing Change or Addition
Ferric Citrate ferric citrate Tablet;Oral Keryx Biopharma Inc Approval
Lantus insulin glargine recombinant Injectable;Injection Sanofi Aventis Us Manufacturing Change or Addition
Lantus Solostar insulin glargine recombinant Injectable;Injection Sanofi Aventis Us Manufacturing Change or Addition
Mirvaso brimonidine tartrate Gel;Topical Galderma Labs Lp Manufacturing Change or Addition
Mucinex Dm dextromethorphan hydrobromide; guaifenesin Tablet, Extended Release;Oral Reckitt Benckiser Manufacturing Change or Addition
Olysio simeprevir sodium Capsule;Oral Janssen Prods Labeling Revision
Pegasys peginterferon alfa-2a Syringe Hoffman-La Roche Labeling Revision
Pegasys peginterferon alfa-2a Vial; Subcutaneous Hoffman-La Roche Labeling Revision

 

 

 

Page Last Updated: 09/19/2014
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