FdaApplication
ANDA 086031
Identifiers
- fda_app_no: ANDA086031
Properties
| Property | Value |
|---|---|
| applicant_name | WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 1987-09-29 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;SUBLINGUAL |
1 product