Application 206021
- Type
- ANDA
- Sponsor
- HEC PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRASUGREL | PRASUGREL HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | PRASUGREL | PRASUGREL HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48792-7821 | prasugrel | Prasugrel hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7822 | prasugrel | Prasugrel hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |