FdaApplication
ANDA 218255
Identifiers
- fda_app_no: ANDA218255
Properties
| Property | Value |
|---|---|
| applicant_name | ZYDUS PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2024-02-15 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL |
3 products