Application 206582
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEPRAZOLE MAGNESIUM | OMEPRAZOLE MAGNESIUM | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59726-297 | Omeprazole | Omeprazole magnesium | P & L Development, LLC | ANDA | Current |
| 59726-297 | Omeprazole | Omeprazole magnesium | P & L Development, LLC | ANDA | Current |
| 59726-737 | Omeprazole | Omeprazole magnesium | P & L Development, LLC | ANDA | Current |
| 59726-737 | Omeprazole | Omeprazole magnesium | P & L Development, LLC | ANDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 50730 | 0 | ORIG | 1 | 2017-12-18 | Cached in FDA.report object storage |