FdaApplication
ANDA 076813
Identifiers
- fda_app_no: ANDA076813
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA INTERNATIONAL PHARMACEUTICALS LLC |
| application_type | ANDA |
| approval_date | 2005-01-07 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL |
2 products