Application 204661
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG | No | No |
| 002 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-5294 | Omeprazole | Omeprazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5294 | Omeprazole | Omeprazole | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 60429-974 | Omeprazole | Omeprazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-974 | Omeprazole | Omeprazole | Golden State Medical Supply, Inc. | ANDA | Current |