Application 090615
- Type
- ANDA
- Sponsor
- WOCKHARDT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG TARTRATE | No | No |
| 002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG TARTRATE | No | No |
| 003 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG TARTRATE | No | No |
| 004 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG TARTRATE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-6589 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6597 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6598 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7530 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 50436-7053 | Metoprolol Succinate | Metoprolol Succinate | Unit Dose Services | ANDA | Current |
| 50436-7056 | Metoprolol Succinate | Metoprolol Succinate | Unit Dose Services | ANDA | Current |
| 55648-734 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt Limited | ANDA | Current |
| 55648-735 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt Limited | ANDA | Current |
| 55648-736 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt Limited | ANDA | Current |
| 55648-737 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt Limited | ANDA | Current |
| 64679-734 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-734 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-735 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-735 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-736 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-736 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-737 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-737 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43240 | ORIG | 2012-02-14 |