Application 212949
- Type
- ANDA
- Sponsor
- CSPC OUYI
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24075-0700 | Esomeprazole magnesium | Esomeprazole magnesium | CSPC Ouyi Pharmaceutical Co., Ltd. | ANDA | Current |
| 24075-1701 | Esomeprazole magnesium | Esomeprazole magnesium | CSPC Ouyi Pharmaceutical Co., Ltd. | ANDA | Current |