Application 203028
- Type
- ANDA
- Sponsor
- PHARMADAX INC
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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60050-001 | Metoprolol Succinate | Metoprolol Succinate | Pharmadax Inc. | ANDA | Current |
| 60050-002 | Metoprolol Succinate | Metoprolol Succinate | Pharmadax Inc. | ANDA | Current |
| 64679-846 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-846 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-847 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 64679-847 | Metoprolol Succinate | Metoprolol Succinate | Wockhardt USA LLC. | ANDA | Current |
| 75834-290 | Metoprolol Succinate | Metoprolol Succinate | Nivagen Pharmaceuticals, Inc. | ANDA | Current |
| 75834-291 | Metoprolol Succinate | Metoprolol Succinate | Nivagen Pharmaceuticals, Inc. | ANDA | Current |