Application 209202
- Type
- ANDA
- Sponsor
- P AND L
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-4187 | Esomeprazole | Esomeprazole | Actavis Pharma, Inc. | ANDA | Current |
| 0591-4187 | Esomeprazole | Esomeprazole | Actavis Pharma, Inc. | ANDA | Current |
| 0591-4187 | Esomeprazole | Esomeprazole | Actavis Pharma, Inc. | ANDA | Current |
| 0591-4187 | Esomeprazole | Esomeprazole | Actavis Pharma, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57982 | ORIG | 2019-03-13 |