Application 040782
- Type
- ANDA
- Sponsor
- IMPAX LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIPYRIDAMOLE | DIPYRIDAMOLE | TABLET;ORAL | 25MG | No | No |
| 002 | DIPYRIDAMOLE | DIPYRIDAMOLE | TABLET;ORAL | 50MG | No | No |
| 003 | DIPYRIDAMOLE | DIPYRIDAMOLE | TABLET;ORAL | 75MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1070 | Dipyridamole | DIPYRIDAMOLE | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1071 | Dipyridamole | DIPYRIDAMOLE | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1072 | Dipyridamole | DIPYRIDAMOLE | Amneal Pharmaceuticals of New York LLC | ANDA | Current |