Application 204920
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE;375MG | No | No |
| 002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE;500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4385 | Naproxen and Esomeprazole Magnesium | naproxen and esomeprazole magnesium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4385 | Naproxen and Esomeprazole Magnesium | naproxen and esomeprazole magnesium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4386 | Naproxen and Esomeprazole Magnesium | naproxen and esomeprazole magnesium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4386 | Naproxen and Esomeprazole Magnesium | naproxen and esomeprazole magnesium | Mylan Pharmaceuticals Inc. | ANDA | Current |