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