FdaApplication
ANDA 216557
Identifiers
- fda_app_no: ANDA216557
Properties
| Property | Value |
|---|---|
| applicant_name | AUROBINDO PHARMA LTD |
| application_type | ANDA |
| approval_date | 2022-11-07 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL |
3 products