Application 202190
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | FOR SUSPENSION;ORAL | 1.875GM/PACKET | No | No |
| 002 | COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | FOR SUSPENSION;ORAL | 3.75GM/PACKET | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68462-620 | Colesevelam Hydrochloride | Colesevelam Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-620 | Colesevelam Hydrochloride | Colesevelam Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-620 | Colesevelam Hydrochloride | Colesevelam Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-620 | Colesevelam Hydrochloride | Colesevelam Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-620 | Colesevelam Hydrochloride | Colesevelam Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-620 | Colesevelam Hydrochloride | Colesevelam Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
| 68462-620 | Colesevelam Hydrochloride | Colesevelam Hydrochloride | Glenmark Pharmaceuticals Inc.,USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55228 | ORIG | 2018-08-20 |