Application 091352
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 10MG | No | No |
| 002 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG | No | No |
| 003 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6917 | Omeprazole | Omeprazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6917 | Omeprazole | Omeprazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6917 | Omeprazole | Omeprazole | Major Pharmaceuticals | ANDA | Current |
| 55154-2332 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-2332 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-2332 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-2332 | Omeprazole | Omeprazole | Cardinal Health 107, LLC | ANDA | Current |
| 55154-2332 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 65841-759 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 65841-759 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 65841-759 | Omeprazole | Omeprazole | Zydus Lifesciences Limited | ANDA | Current |
| 65841-759 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 65841-760 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 65841-760 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 65841-760 | Omeprazole | Omeprazole | Zydus Lifesciences Limited | ANDA | Current |
| 65841-760 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 65841-761 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 65841-761 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 65841-761 | Omeprazole | Omeprazole | Zydus Lifesciences Limited | ANDA | Current |
| 65841-761 | Omeprazole | Omeprazole | Cadila Healthcare Limited | ANDA | Current |
| 68382-411 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-411 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-411 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-411 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-411 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-411 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-411 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-412 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-412 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-412 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-412 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-412 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-412 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-412 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-500 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-500 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-500 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-500 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-500 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-500 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-500 | Omeprazole | Omeprazole | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |