Application 017963
- Type
- NDA
- Sponsor
- US PHARMS HOLDINGS I
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOPRESSOR | METOPROLOL TARTRATE | TABLET;ORAL | 50MG | Yes | No |
| 002 | LOPRESSOR | METOPROLOL TARTRATE | TABLET;ORAL | 100MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 30698-458 | Lopressor | metoprolol tartrate | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-458 | Lopressor | metoprolol tartrate | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-459 | Lopressor | metoprolol tartrate | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-459 | Lopressor | metoprolol tartrate | Validus Pharmaceuticals LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77141 | SUPPL | 2024-01-04 |
| 77175 | SUPPL | 2024-01-03 |
| 74711 | SUPPL | 2023-07-07 |
| 74705 | SUPPL | 2023-07-06 |
| 13967 | SUPPL | 2013-03-15 |
| 11100 | SUPPL | 2013-03-15 |
| 11099 | SUPPL | 2013-01-11 |
| 761 | SUPPL | 2012-12-26 |
| 33379 | SUPPL | 2011-03-21 |
| 760 | SUPPL | 2010-01-06 |
| 33378 | SUPPL | 2009-11-23 |
| 759 | SUPPL | 2008-07-30 |
| 33377 | SUPPL | 2008-07-29 |
| 13966 | SUPPL | 2008-01-09 |
| 758 | SUPPL | 2006-09-18 |
| 13965 | SUPPL | 2003-09-25 |