Application 076515
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-2234 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2234 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2234 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2234 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0781-2234 | Omeprazole | Omeprazole | Sandoz Inc | ANDA | Current |
| 0904-6144 | Omeprazole | Omeprazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6144 | Omeprazole | Omeprazole | Major Pharmaceuticals | ANDA | Current |
| 55154-7277 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-7277 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 70518-1261 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1261 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1261 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1261 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1261 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70934-336 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-336 | Omeprazole | Omeprazole | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |