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Application 207882
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43547-283 | TELMISARTAN | TELMISARTAN | Solco Healthcare US, LLC | ANDA | Current |
| 43547-283 | TELMISARTAN | TELMISARTAN | Solco Healthcare US, LLC | ANDA | Current |
| 43547-283 | TELMISARTAN | TELMISARTAN | Solco Healthcare US, LLC | ANDA | Current |
| 43547-284 | Telmisartan | Telmisartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-284 | Telmisartan | Telmisartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-284 | Telmisartan | Telmisartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-285 | Telmisartan | Telmisartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-285 | Telmisartan | Telmisartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-285 | Telmisartan | Telmisartan | Solco Healthcare US, LLC | ANDA | Current |
| 70518-3556 | Telmisartan | Telmisartan | REMEDYREPACK INC. | ANDA | Current |
| 71335-2173 | Telmisartan | Telmisartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-2191 | Telmisartan | Telmisartan | Bryant Ranch Prepack | ANDA | Current |