Application 078279
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No |
| 002 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6580 | Esomeprazole Magnesium | Esomeprazole Magnesium | Major Pharmaceuticals | ANDA | Current |
| 0904-6581 | Esomeprazole Magnesium | Esomeprazole Magnesium | Major Pharmaceuticals | ANDA | Current |
| 0904-6581 | Esomeprazole Magnesium | Esomeprazole Magnesium | Major Pharmaceuticals | ANDA | Current |
| 0904-6581 | Esomeprazole Magnesium | Esomeprazole Magnesium | Major Pharmaceuticals | ANDA | Current |
| 16714-979 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-979 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-979 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-979 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 43598-509 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Inc | ANDA | Current |
| 43598-509 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Inc | ANDA | Current |
| 43598-509 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Inc | ANDA | Current |
| 43598-509 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Inc | ANDA | Current |
| 43598-510 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Inc | ANDA | Current |
| 43598-510 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Inc | ANDA | Current |
| 43598-510 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Inc | ANDA | Current |
| 43598-510 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Inc | ANDA | Current |
| 50090-2943 | Esomeprazole Magnesium | Esomeprazole Magnesium | A-S Medication Solutions | ANDA | Current |
| 50090-3023 | Esomeprazole Magnesium | Esomeprazole Magnesium | A-S Medication Solutions | ANDA | Current |
| 50090-3023 | Esomeprazole Magnesium | Esomeprazole Magnesium | A-S Medication Solutions | ANDA | Current |
| 50090-3023 | Esomeprazole Magnesium | Esomeprazole Magnesium | A-S Medication Solutions | ANDA | Current |
| 50090-3023 | Esomeprazole Magnesium | Esomeprazole Magnesium | A-S Medication Solutions | ANDA | Current |
| 50090-5134 | Esomeprazole Magnesium | Esomeprazole Magnesium | A-S Medication Solutions | ANDA | Current |
| 50090-5134 | Esomeprazole Magnesium | Esomeprazole Magnesium | A-S Medication Solutions | ANDA | Current |
| 55111-492 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-493 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 60687-235 | Esomeprazole Magnesium | Esomeprazole Magnesium | American Health Packaging | ANDA | Current |
| 60687-246 | Esomeprazole Magnesium | Esomeprazole Magnesium | American Health Packaging | ANDA | Current |
| 61919-834 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | DirectRX | ANDA | Current |
| 63187-964 | Esomeprazole Magnesium | Esomeprazole Magnesium | Proficient Rx LP | ANDA | Current |
| 63187-964 | Esomeprazole Magnesium | Esomeprazole Magnesium | Proficient Rx LP | ANDA | Current |
| 63187-964 | Esomeprazole Magnesium | Esomeprazole Magnesium | Proficient Rx LP | ANDA | Current |
| 63187-964 | Esomeprazole Magnesium | Esomeprazole Magnesium | Proficient Rx LP | ANDA | Current |
| 68071-4825 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 68071-4825 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 70518-3044 | Esomeprazole Magnesium | Esomeprazole Magnesium | REMEDYREPACK INC. | ANDA | Current |
| 70518-3044 | Esomeprazole Magnesium | Esomeprazole Magnesium | REMEDYREPACK INC. | ANDA | Current |
| 71205-143 | Esomeprazole Magnesium | Esomeprazole Magnesium | Proficient Rx LP | ANDA | Current |
| 71205-143 | Esomeprazole Magnesium | Esomeprazole Magnesium | Proficient Rx LP | ANDA | Current |
| 71205-143 | Esomeprazole Magnesium | Esomeprazole Magnesium | Proficient Rx LP | ANDA | Current |
| 71335-0709 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 76519-1173 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | H.J. Harkins Company, Inc. | ANDA | Current |
| 76519-1173 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | H.J. Harkins Company, Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 39555 | ORIG | 2015-11-25 |
| 9137 | ORIG | 2015-10-02 |