Application 022401
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TWYNSTA | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 5MG BASE;40MG | Yes | No |
| 002 | TWYNSTA | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 10MG BASE;40MG | Yes | No |
| 003 | TWYNSTA | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 5MG BASE;80MG | Yes | No |
| 004 | TWYNSTA | AMLODIPINE BESYLATE; TELMISARTAN | TABLET;ORAL | EQ 10MG BASE;80MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0124 | Twynsta | telmisartan/amlodipine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0124 | Twynsta | telmisartan/amlodipine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0125 | Twynsta | telmisartan/amlodipine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0125 | Twynsta | telmisartan/amlodipine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0126 | Twynsta | telmisartan/amlodipine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0126 | Twynsta | telmisartan/amlodipine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0127 | Twynsta | telmisartan/amlodipine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0127 | Twynsta | telmisartan/amlodipine | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |