Application 209038
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
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 |
|---|---|---|---|---|---|
| 50090-4371 | Colesevelam HCL | Colesevelam HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4371 | Colesevelam HCL | Colesevelam HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4371 | Colesevelam HCL | Colesevelam HCL | A-S Medication Solutions | ANDA | Current |
| 63629-8767 | Colesevelam HCL | Colesevelam HCL | Bryant Ranch Prepack | ANDA | Current |
| 63629-8767 | Colesevelam HCL | Colesevelam HCL | Bryant Ranch Prepack | ANDA | Current |
| 63629-8767 | Colesevelam HCL | Colesevelam HCL | Bryant Ranch Prepack | ANDA | Current |
| 67877-506 | Colesevelam HCL | Colesevelam HCL | Ascend Laboratories, LLC | ANDA | Current |
| 67877-506 | Colesevelam HCL | Colesevelam HCL | Ascend Laboratories, LLC | ANDA | Current |
| 67877-506 | Colesevelam HCL | Colesevelam HCL | Ascend Laboratories, LLC | ANDA | Current |
| 67877-506 | Colesevelam HCL | Colesevelam HCL | Ascend Laboratories, LLC | ANDA | Current |