FdaApplication
ANDA 203995
Identifiers
- fda_app_no: ANDA203995
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL PHARMACEUTICALS |
| application_type | ANDA |
| approval_date | 2016-11-25 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL |
| DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL |
2 products