Application 205897
- Type
- ANDA
- Sponsor
- PANACEA BIOTEC 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 |
|---|
| 43817-239 | Prasugrel | Prasugrel | Panacea Biotec Limited | ANDA | Current |
| 43817-239 | Prasugrel | Prasugrel | Panacea Biotec Ltd. | ANDA | Current |
| 43817-240 | Prasugrel | Prasugrel | Panacea Biotec Limited | ANDA | Current |
| 43817-240 | Prasugrel | Prasugrel | Panacea Biotec Ltd. | ANDA | Current |
| 51407-247 | Prasugrel | Prasugrel | Golden State Medical Supply | ANDA | Current |
| 51407-247 | Prasugrel | Prasugrel | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-247 | Prasugrel | Prasugrel | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-248 | Prasugrel | Prasugrel | Golden State Medical Supply | ANDA | Current |
| 51407-248 | Prasugrel | Prasugrel | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-248 | Prasugrel | Prasugrel | Golden State Medical Supply, Inc. | ANDA | Current |
| 60505-4642 | Prasugrel | Prasugrel | Apotex Corp. | ANDA | Current |
| 60505-4642 | Prasugrel | Prasugrel | Apotex Corp. | ANDA | Current |
| 60505-4643 | Prasugrel | Prasugrel | Apotex Corp. | ANDA | Current |
| 60505-4643 | Prasugrel | Prasugrel | Apotex Corp. | ANDA | Current |
| 60687-412 | Prasugrel | Prasugrel | American Health Packaging | ANDA | Current |
| 60687-412 | Prasugrel | Prasugrel | American Health Packaging | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50122 | ORIG | 2017-10-19 |