Application 206877
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0363-1008 | Acid Reducer | Omeprazole | WALGREEN CO. | ANDA | Current |
| 0363-1008 | Acid Reducer | Omeprazole | WALGREEN CO. | ANDA | Current |
| 0536-1322 | Acid Reducer | Omeprazole | Rugby Laboratories | ANDA | Current |
| 0536-1322 | Acid Reducer | Omeprazole | Rugby Laboratories | ANDA | Current |
| 10202-722 | Acid Reducer | Omeprazole | 7-Eleven | ANDA | Current |
| 10202-722 | Acid Reducer | Omeprazole | 7-Eleven | ANDA | Current |
| 10202-722 | Acid Reducer | Omeprazole | 7-Eleven | ANDA | Current |
| 10202-722 | Acid Reducer | Omeprazole | 7-Eleven | ANDA | Current |
| 10202-722 | Acid Reducer | Omeprazole | 7-Eleven | ANDA | Current |
| 37835-189 | Acid Reducer | Omeprazole | Bi-Mart | ANDA | Current |
| 37835-189 | Acid Reducer | Omeprazole | Bi-Mart | ANDA | Current |
| 37835-189 | Acid Reducer | Omeprazole | Bi-Mart | ANDA | Current |
| 49035-983 | Acid Reducer | Omeprazole | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-983 | Acid Reducer | Omeprazole | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-983 | Acid Reducer | Omeprazole | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-983 | Acid Reducer | Omeprazole | Wal-Mart Stores, Inc. | ANDA | Current |
| 53943-016 | Acid Reducer | Omeprazole | DISCOUNT DRUG MART | ANDA | Current |
| 53943-016 | Acid Reducer | Omeprazole | DISCOUNT DRUG MART | ANDA | Current |
| 53943-016 | Acid Reducer | Omeprazole | DISCOUNT DRUG MART | ANDA | Current |
| 53943-016 | Acid Reducer | Omeprazole | DISCOUNT DRUG MART | ANDA | Current |
| 55315-996 | Acid Reducer | Omeprazole | Fred's, Inc. | ANDA | Current |
| 55315-996 | Acid Reducer | Omeprazole | Fred's, Inc. | ANDA | Current |
| 55315-996 | Acid Reducer | Omeprazole | Fred's, Inc. | ANDA | Current |
| 55319-037 | Acid Reducer | Omeprazole | Family Dollar, Inc. | ANDA | Current |
| 55319-037 | Acid Reducer | Omeprazole | Family Dollar, Inc. | ANDA | Current |
| 55319-037 | Acid Reducer | Omeprazole | Family Dollar, Inc. | ANDA | Current |
| 55319-037 | Acid Reducer | Omeprazole | Family Dollar, Inc. | ANDA | Current |
| 58602-729 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-729 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-729 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-729 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-729 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-729 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-729 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-826 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-826 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-826 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-850 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-850 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 58602-850 | Acid Reducer | Omeprazole | Aurohealth LLC | ANDA | Current |
| 63941-006 | Acid Reducer | Omeprazole | Best Choice | ANDA | Current |
| 63941-006 | Acid Reducer | Omeprazole | Best Choice | ANDA | Current |
| 63941-006 | Acid Reducer | Omeprazole | Best Choice | ANDA | Current |
| 63941-006 | Acid Reducer | Omeprazole | Best Choice | ANDA | Current |
| 67091-316 | Acid Reducer | Omeprazole | Winco Foods, LLC. | ANDA | Current |
| 67091-316 | Acid Reducer | Omeprazole | Winco Foods, LLC. | ANDA | Current |
| 67091-316 | Acid Reducer | Omeprazole | Winco Foods, LLC. | ANDA | Current |
| 69618-054 | Acid Reducer | Omeprazole | RELIABLE 1 LABORATORIES LLC | ANDA | Current |
| 69618-054 | Acid Reducer | Omeprazole | RELIABLE 1 LABORATORIES LLC | ANDA | Current |
| 69842-941 | Acid Reducer | Omeprazole | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-941 | Acid Reducer | Omeprazole | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-941 | Acid Reducer | Omeprazole | CVS Pharmacy, Inc. | ANDA | Current |
| 70000-0521 | Acid Reducer | Omeprazole | Cardinal Health | ANDA | Current |
| 70000-0521 | Acid Reducer | Omeprazole | Cardinal Health | ANDA | Current |
| 70000-0521 | Acid Reducer | Omeprazole | Cardinal Health | ANDA | Current |
| 70000-0521 | Acid Reducer | Omeprazole | Cardinal Health | ANDA | Current |
| 80136-852 | Acid Reducer | Omeprazole | NORTHEAST PHARMA | ANDA | Current |
| 80136-852 | Acid Reducer | Omeprazole | NORTHEAST PHARMA | ANDA | Current |
| 80136-852 | Acid Reducer | Omeprazole | NORTHEAST PHARMA | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50994 | ORIG | 2018-01-08 |