Application 212507
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69230-320 | Esomeprazole Magnesium | Esomeprazole Magnesium | Camber Consumer Care | ANDA | Current |
| 69230-320 | Esomeprazole Magnesium | Esomeprazole Magnesium | Camber Consumer Care Inc | ANDA | Current |