Application 078560
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EZETIMIBE | EZETIMIBE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49884-228 | Ezetimibe | Ezetimibe | Par Pharmaceutical Inc | ANDA | Current |
| 49884-228 | Ezetimibe | Ezetimibe | Par Pharmaceutical Inc | ANDA | Current |
| 50090-2717 | Ezetimibe | Ezetimibe | A-S Medication Solutions | ANDA | Current |
| 60687-284 | Ezetimibe | Ezetimibe | American Health Packaging | ANDA | Current |
| 68462-226 | Ezetimibe | Ezetimibe | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-226 | Ezetimibe | Ezetimibe | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31372 | ORIG | 2015-06-29 |