Application 076411
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | TABLET;ORAL | 1GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1754 | Methenamine Hippurate | Methenamine Hippurate | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1754 | Methenamine Hippurate | Methenamine Hippurate | Impax Generics | ANDA | Current |
| 64720-139 | Methenamine Hippurate | Methenamine Hippurate | CorePharma, LLC | ANDA | Current |
| 64720-139 | Methenamine Hippurate | Methenamine Hippurate | CorePharma, LLC | ANDA | Current |
| 68151-0984 | Methenamine Hippurate | Methenamine Hippurate | Carilion Materials Management | ANDA | Current |