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