Application 204152
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
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 |
|---|---|---|---|---|---|
| 0113-0045 | Good Sense omeprazole | Omeprazole magnesium | L. Perrigo Company | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10302 | ORIG | 2015-08-03 |