Application 204164
- Type
- ANDA
- Sponsor
- JUBILANT GENERICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 20MG | No | No |
| 002 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 40MG | No | No |
| 003 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 80MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59746-439 | Telmisartan | Telmisartan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-440 | Telmisartan | Telmisartan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-441 | Telmisartan | Telmisartan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |