Application 078898
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | TABLET;ORAL | EQ 4MG BASE | No | No |
| 002 | GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | TABLET;ORAL | EQ 8MG BASE | No | No |
| 003 | GALANTAMINE HYDROBROMIDE | GALANTAMINE HYDROBROMIDE | TABLET;ORAL | EQ 12MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65841-755 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 65841-755 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 65841-755 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 65841-755 | Galantamine | Galantamine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-756 | Galantamine | Galantamine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-756 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 65841-756 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 65841-756 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 65841-757 | Galantamine | Galantamine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-757 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 65841-757 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 65841-757 | Galantamine | Galantamine | Cadila Healthcare Limited | ANDA | Current |
| 68382-177 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-177 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-177 | galantamine | galantamine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-177 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-178 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-178 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-178 | galantamine | galantamine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-178 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-179 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-179 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-179 | galantamine | galantamine | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-179 | galantamine | galantamine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |