Application 213351
- Type
- ANDA
- Sponsor
- POLYGEN PHARMS
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 |
|---|---|---|---|---|---|
| 52605-082 | clopidogrel | clopidogrel | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-082 | clopidogrel | clopidogrel | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-082 | clopidogrel | clopidogrel | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-083 | Clopidogrel | Clopidogrel | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-083 | Clopidogrel | Clopidogrel | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-083 | Clopidogrel | Clopidogrel | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |