Application 204206
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55111-289 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-289 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-289 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-289 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-701 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-701 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-701 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-701 | Naproxen and esomeprazole magnesium | Naproxen and esomeprazole magnesium | Dr. Reddy's Laboratories Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 62235 | ORIG | 2020-03-23 |