Application 078490
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | No | No |
| 002 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 10MG | No | No |
| 003 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-123 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-123 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-123 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-123 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-634 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 55111-643 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-643 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-643 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-643 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-643 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-643 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-643 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-644 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-644 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-644 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-644 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-644 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-644 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-644 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-645 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-645 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-645 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-645 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-645 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-645 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-645 | Omeprazole | Omeprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55700-410 | Omeprazole | Omeprazole | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-410 | Omeprazole | Omeprazole | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-410 | Omeprazole | Omeprazole | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-410 | Omeprazole | Omeprazole | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60687-608 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 60687-608 | Omeprazole | Omeprazole | American Health Packaging | ANDA | Current |
| 68071-1943 | Omeprazole | Omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2741 | Omeprazole | Omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 72789-257 | Omeprazole | Omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 80425-0109 | Prilosec | Omeprazole 40mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0109 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0109 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0109 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 82009-023 | Omeprazole | Omeprazole | Quallent Pharmaceuticals Health LLC | ANDA | Current |