FdaApplication
ANDA 075522
Identifiers
- fda_app_no: ANDA075522
Properties
| Property | Value |
|---|---|
| applicant_name | DEXCEL LTD |
| application_type | ANDA |
| approval_date | 2000-04-17 |
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