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