Application 211751
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 20MG BASE/PACKET | No | No |
| 002 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | FOR SUSPENSION, DELAYED RELEASE;ORAL | EQ 40MG BASE/PACKET | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-528 | Esomeprazole magnesium | Esomeprazole magnesium | Cipla USA Inc. | ANDA | Current |
| 69097-528 | Esomeprazole magnesium | Esomeprazole magnesium | Cipla USA Inc. | ANDA | Current |
| 69097-528 | Esomeprazole magnesium | Esomeprazole magnesium | Cipla USA Inc. | ANDA | Current |
| 69097-528 | Esomeprazole magnesium | Esomeprazole magnesium | Cipla USA Inc. | ANDA | Current |
| 69097-529 | Esomeprazole magnesium | Esomeprazole magnesium | Cipla USA Inc. | ANDA | Current |
| 69097-529 | Esomeprazole magnesium | Esomeprazole magnesium | Cipla USA Inc. | ANDA | Current |
| 69097-529 | Esomeprazole magnesium | Esomeprazole magnesium | Cipla USA Inc. | ANDA | Current |
| 69097-529 | Esomeprazole magnesium | Esomeprazole magnesium | Cipla USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63099 | ORIG | 2020-05-19 |