Application 078003
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0093-6450 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6450 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6450 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6450 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6450 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6451 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6451 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6451 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6451 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-6451 | Esomeprazole Magnesium | Esomeprazole Magnesium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 42708-024 | Esomeprazole Magnesium | Esomeprazole Magnesium | QPharma Inc | ANDA | Current |
| 42708-024 | Esomeprazole Magnesium | Esomeprazole Magnesium | QPharma Inc | ANDA | Current |
| 42708-024 | Esomeprazole Magnesium | Esomeprazole Magnesium | QPharma Inc | ANDA | Current |
| 50436-3120 | Esomeprazole Magnesium | Esomeprazole Magnesium | Unit Dose Services | ANDA | Current |
| 59088-701 | PharmapureRx ESOMEP-EZS | esomeprazole magnesium | PureTek Corporation | ANDA | Current |
| 61919-243 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | DIRECT RX | ANDA | Current |
| 61919-243 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | DIRECT RX | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57222 | ORIG | 2019-01-15 |
| 39547 | ORIG | 2015-02-17 |
| 9107 | ORIG | 2015-01-28 |