Application 208531
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TICAGRELOR | TICAGRELOR | TABLET;ORAL | 90MG | No | No |
| 002 | TICAGRELOR | TICAGRELOR | TABLET;ORAL | 60MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69238-1134 | ticagrelor | ticagrelor | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1134 | ticagrelor | ticagrelor | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1134 | ticagrelor | ticagrelor | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1134 | Ticagrelor | Ticagrelor | Amneal Pharmaceuticals LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57716 | ORIG | 2019-02-21 |