Application 210207
- Type
- ANDA
- Sponsor
- PIRAMAL HLTHCARE UK
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 |
|---|
| 70436-007 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-007 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-007 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-008 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-008 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-008 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-009 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-009 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |
| 70436-009 | cinacalcet hydrochloride | cinacalcet hydrochloride | Slate Run Pharmaceuticals | ANDA | Current |