Application 077665
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | TABLET;ORAL | EQ 75MG BASE | No | No |
| 002 | CLOPIDOGREL BISULFATE | CLOPIDOGREL BISULFATE | TABLET;ORAL | EQ 300MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-3627 | Clopidogrel Bisulfate | clopidogrel | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3627 | Clopidogrel Bisulfate | clopidogrel | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-558 | Clopidogrel Bisulfate | clopidogrel | Mylan Institutional Inc. | ANDA | Current |
| 55154-5388 | Clopidogrel Bisulfate | clopidogrel | Cardinal Health | ANDA | Current |
| 55154-5388 | Clopidogrel Bisulfate | clopidogrel | Cardinal Health | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9074 | ORIG | 2012-05-18 |