Application 205888
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|
| 65862-829 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-829 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-829 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-829 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-829 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-829 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-830 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-830 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-830 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-830 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-830 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
| 65862-830 | Prasugrel | Prasugrel | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50112 | ORIG | 2017-10-19 |