Application 208971
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | No | No |
| 002 | CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 60MG BASE | No | No |
| 003 | CINACALCET HYDROCHLORIDE | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 90MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70710-1000 | Cinacalcet | Cinacalcet | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1001 | Cinacalcet | Cinacalcet | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1002 | Cinacalcet | Cinacalcet | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1054 | Cinacalcet | Cinacalcet | Cadila Healthcare Limited | ANDA | Current |
| 70771-1055 | Cinacalcet | Cinacalcet | Cadila Healthcare Limited | ANDA | Current |
| 70771-1056 | Cinacalcet | Cinacalcet | Cadila Healthcare Limited | ANDA | Current |