Apr 052018
 

April 5, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Femara
NDA #020726
Letrozole Tablet; Oral SUPPL-35 Novartis Pharms Labeling Approved
Nallpen In Plastic Container
NDA #050655
Nafcillin Sodium Injectable; Injection SUPPL-26 Baxter Hlthcare Labeling Approved
Amlodipine Besylate
ANDA #078477
Amlodipine Besylate Tablet; Oral SUPPL-19 Amneal Pharms Ny Labeling Approved
Apr 042018
 

April 4, 2018

Apr 042018
 

April 4, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Tamiflu
NDA #021087
Oseltamivir Phosphate Capsule; Oral SUPPL-69 Roche Labeling Approved
Tamiflu
NDA #021246
Oseltamivir Phosphate For Suspension; Oral SUPPL-52 Roche Labeling Approved
Acitretin
ANDA #091455
Acitretin Capsule; Oral SUPPL-12 Barr Labs Inc Labeling Approved
Acitretin
ANDA #202897
Acitretin Capsule; Oral SUPPL-12 Teva Pharms Usa Labeling Approved
Rocuronium Bromide
ANDA #205656
Rocuronium Bromide Injectable; Injection ORIG-1 Gland Chems Pvt Approved
Testosterone Cypionate
ANDA #207742
Testosterone Cypionate Injectable; Injection SUPPL-1 Luitpold Pharms Inc Manufacturing (CMC) Approved
Testosterone Cypionate
ANDA #207742
Testosterone Cypionate Injectable; Injection SUPPL-1 Luitpold Pharms Inc Manufacturing (CMC) Approved
Apr 032018
 
Apr 032018
 

April 3, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Flagyl
NDA #012623
Metronidazole Tablet; Oral SUPPL-67 Gd Searle Llc Labeling Approved
Metronidazole In Plastic Container
NDA #018890
Metronidazole Injectable; Injection SUPPL-52 Hospira Labeling Approved
Flagyl
NDA #020334
Metronidazole Capsule; Oral SUPPL-10 Gd Searle Llc Labeling Approved
Flagyl Er
NDA #020868
Metronidazole Tablet, Extended Release; Oral SUPPL-12 Gd Searle Llc Labeling Approved
Prilosec Otc
NDA #021229
Omeprazole Magnesium Tablet, Delayed Release; Oral SUPPL-31 Astrazeneca Pharms Labeling Approved
Emend
NDA #022023
Fosaprepitant Dimeglumine Powder; Intravenous SUPPL-17 Merck and Co Inc Efficacy Approved
Besivance
NDA #022308
Besifloxacin Hydrochloride Suspension/Drops; Ophthalmic SUPPL-13 Bausch and Lomb Labeling Approved
Amlodipine Besylate
ANDA #076418
Amlodipine Besylate Tablet; Oral SUPPL-20 Mylan Pharms Inc Labeling Approved
Amlodipine Besylate
ANDA #076418
Amlodipine Besylate Tablet; Oral SUPPL-20 Mylan Pharms Inc Labeling Approved
Amlodipine Besylate
ANDA #077974
Amlodipine Besylate Tablet; Oral SUPPL-4 Sun Pharm Inds Ltd Labeling Approved
Amlodipine Besylate
ANDA #077974
Amlodipine Besylate Tablet; Oral SUPPL-5 Sun Pharm Inds Ltd Labeling Approved
Rituxan
BLA #103705
Rituximab Vial SUPPL-5453 Genentech Labeling Approved
Amlodipine Besylate
ANDA #201380
Amlodipine Besylate Tablet; Oral SUPPL-7 Macleods Pharms Ltd Labeling Approved
Amlodipine Besylate
ANDA #201380
Amlodipine Besylate Tablet; Oral SUPPL-7 Macleods Pharms Ltd Labeling Approved
Apr 022018
 

April 2, 2018

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ultravist 150
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist 240
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist 300
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist 300 In Plastic Container
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist 370
NDA #020220
Iopromide Injectable; Injection SUPPL-45 Bayer Hlthcare Labeling Approved
Ultravist (Pharmacy Bulk)
NDA #021425
Iopromide Injectable; Injection SUPPL-28 Bayer Hlthcare Labeling Approved
Xyzal
NDA #022064
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-36 Sanofi-Aventis Us Labeling Approved
Xyzal
NDA #022157
Levocetirizine Dihydrochloride Solution; Oral SUPPL-18 Sanofi-Aventis Us Labeling Approved
Bydureon
NDA #022200
Exenatide Synthetic For Suspension, Extended Release; Subcutaneous SUPPL-26 Astrazeneca Ab Efficacy Approved
Bydureon Pen
NDA #022200
Exenatide Synthetic For Suspension, Extended Release; Subcutaneous SUPPL-26 Astrazeneca Ab Efficacy Approved
Amlodipine Besylate
ANDA #076719
Amlodipine Besylate Tablet; Oral SUPPL-11 Apotex Labeling Approved
Amlodipine Besylate
ANDA #077262
Amlodipine Besylate Tablet; Oral SUPPL-6 West-Ward Pharms Int Labeling Approved
Amlodipine Besylate
ANDA #078414
Amlodipine Besylate Tablet; Oral SUPPL-13 Vintage Labeling Approved
Amlodipine Besylate
ANDA #078414
Amlodipine Besylate Tablet; Oral SUPPL-13 Vintage Labeling Approved
Amlodipine Besylate
ANDA #202553
Amlodipine Besylate Tablet; Oral SUPPL-1 Accord Hlthcare Labeling Approved
Amlodipine Besylate
ANDA #202553
Amlodipine Besylate Tablet; Oral SUPPL-2 Accord Hlthcare Labeling Approved
Striverdi Respimat
NDA #203108
Olodaterol Hydrochloride Spray, Metered; Inhalation SUPPL-6 Boehringer Ingelheim Labeling Approved
Mar 072016
 

March 7, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Chorionic Gonadotropin gonadotropin, chorionic Injectable;Injection Ferring Manufacturing Change or Addition
Lopinavir; Ritonavir lopinavir;ritonavir Tablet;Oral Macleods Pharms Ltd Tentative Approval
Namenda memantine hydrochloride Tablet;Oral Forest Labs Llc Manufacturing Change or Addition
Oxaydo oxycodone hydrochloride Tablet;Oral Egalet Us Inc Manufacturing Change or Addition
Oxiconazole Nitrate oxiconazole nitrate Cream;Topical Taro Approval
Ryzodeg 70/30 insulin aspart; insulin degludec Solution;Subcutaneous Novo Nordisk Inc Manufacturing Change or Addition
Mar 042016
 

March 4, 2016

Mar 042016
 

March 4, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adcetris brentuximab vedotin Injectable; Injection Seattle Genetics Labeling Revision
H.P. Acthar Gel corticotropin Injectable;Injection Mallinckrodt Ard Manufacturing Change or Addition
Imbruvica ibrutinib Capsule;Oral Pharmacyclics Inc Supplement
Lamivudine lamivudine Tablet;Oral Mylan Pharms Inc Approval
Lasix furosemide Tablet;Oral Us Pharm Holdings Labeling Revision
Maxipime cefepime hydrochloride Injectable;Injection Hospira Inc Manufacturing Change or Addition
Potassium Chloride potassium chloride Capsule, Extended Release;Oral Tris Pharma Inc Approval
Sodium Bicarbonate sodium bicarbonate Injectable;Injection Hospira Inc Approval
Varithena polidocanol Solution;Intravenous Provensis Manufacturing Change or Addition
Yaz drospirenone; ethinyl estradiol Tablet;Oral Bayer Hlthcare Manufacturing Change or Addition