Application 209403
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-103 | Cinacalcet | Cinacalcet | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-104 | Cinacalcet | Cinacalcet | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-105 | Cinacalcet | Cinacalcet | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 72865-150 | Cinacalcet | Cinacalcet | XLCare Pharmaceuticals Inc. | ANDA | Current |
| 72865-151 | Cinacalcet | Cinacalcet | XLCare Pharmaceuticals Inc. | ANDA | Current |
| 72865-152 | Cinacalcet | Cinacalcet | XLCare Pharmaceuticals Inc. | ANDA | Current |