Application 207765
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | TABLET;ORAL | 625MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68382-619 | Colesevelam | Colesevelam | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-619 | Colesevelam | Colesevelam | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-619 | Colesevelam | Colesevelam | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-619 | Colesevelam | Colesevelam | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1368 | COLESEVELAM | COLESEVELAM | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1368 | COLESEVELAM | COLESEVELAM | Cadila Healthcare Limited | ANDA | Current |
| 70771-1368 | COLESEVELAM | COLESEVELAM | Cadila Healthcare Limited | ANDA | Current |