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Application 207016
- Type
- ANDA
- Sponsor
- MICRO LABS
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 |
|---|
| 42571-226 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-226 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-226 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-226 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-226 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-227 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-227 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-227 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-227 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-227 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-228 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-228 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-228 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-228 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 42571-228 | TELMISARTAN | Telmisartan | Micro Labs Limited | ANDA | Current |
| 71335-1841 | TELMISARTAN | Telmisartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-1841 | TELMISARTAN | Telmisartan | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 49970 | ORIG | 2017-10-06 |