Application 213699
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 |
|---|---|---|---|---|---|
| 27241-202 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-203 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Ajanta Pharma USA Inc. | ANDA | Current |