Application 208670
- Type
- ANDA
- Sponsor
- BIONPHARMA INC
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 |
|---|---|---|---|---|---|
| 63629-2446 | COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2446 | COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 69452-158 | COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | Bionpharma Inc. | ANDA | Current |
| 69452-158 | COLESEVELAM HYDROCHLORIDE | colesevelam hydrochloride | Bionpharma Inc. | ANDA | Current |