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Application 205987
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-272 | Prasugrel | Prasugrel | Accord Healthcare Inc. | ANDA | Current |
| 16729-272 | Prasugrel | Prasugrel | Accord Healthcare Inc. | ANDA | Current |
| 16729-272 | Prasugrel | Prasugrel | Accord Healthcare Inc. | ANDA | Current |
| 16729-272 | Prasugrel | Prasugrel | Accord Healthcare Inc. | ANDA | Current |
| 16729-273 | Prasugrel | Prasugrel | Accord Healthcare Inc. | ANDA | Current |
| 16729-273 | Prasugrel | Prasugrel | Accord Healthcare Inc. | ANDA | Current |
| 16729-273 | Prasugrel | Prasugrel | Accord Healthcare Inc. | ANDA | Current |
| 16729-273 | Prasugrel | Prasugrel | Accord Healthcare Inc. | ANDA | Current |
| 50090-5169 | Prasugrel | Prasugrel | A-S Medication Solutions | ANDA | Current |
| 50090-5169 | Prasugrel | Prasugrel | A-S Medication Solutions | ANDA | Current |
| 50090-5169 | Prasugrel | Prasugrel | A-S Medication Solutions | ANDA | Current |