Application 204724
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No |
| 002 | SEVELAMER HYDROCHLORIDE | SEVELAMER HYDROCHLORIDE | TABLET;ORAL | 800MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60687-449 | Sevelamer Hydrochloride | Sevelamer Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-449 | Sevelamer Hydrochloride | Sevelamer Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-449 | Sevelamer Hydrochloride | Sevelamer Hydrochloride | American Health Packaging | ANDA | Current |
| 68462-446 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-446 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-446 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-446 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-446 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-447 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-447 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-447 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-447 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-447 | sevelamer hydrochloride | sevelamer hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57958 | ORIG | 2019-03-12 |