Application 021688
- Type
- NDA
- Sponsor
- AMGEN
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SENSIPAR | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | Yes | No |
| 002 | SENSIPAR | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 60MG BASE | Yes | No |
| 003 | SENSIPAR | CINACALCET HYDROCHLORIDE | TABLET;ORAL | EQ 90MG BASE | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-3529 | Sensipar | cinacalcet hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-3529 | Sensipar | cinacalcet hydrochloride | A-S Medication Solutions | NDA | Current |
| 50090-4470 | Sensipar | cinacalcet hydrochloride | A-S Medication Solutions | NDA | Current |
| 53808-0577 | Sensipar | cinacalcet hydrochloride | State of Florida DOH Central Pharmacy | NDA | Current |
| 53808-0578 | Sensipar | cinacalcet hydrochloride | State of Florida DOH Central Pharmacy | NDA | Current |
| 55513-073 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-073 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-073 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-073 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-074 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-074 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-074 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-074 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-075 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-075 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-075 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 55513-075 | Sensipar | cinacalcet hydrochloride | Amgen Inc | NDA | Current |
| 68151-4740 | Sensipar | cinacalcet hydrochloride | Carilion Materials Management | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 61219 | SUPPL | 2019-12-10 |
| 61170 | SUPPL | 2019-12-06 |
| 58207 | SUPPL | 2019-04-04 |
| 58206 | SUPPL | 2019-04-04 |
| 58166 | SUPPL | 2019-04-01 |
| 58165 | SUPPL | 2019-04-01 |
| 48540 | SUPPL | 2017-05-25 |
| 48529 | SUPPL | 2017-05-25 |
| 48400 | SUPPL | 2017-05-17 |
| 48389 | SUPPL | 2017-05-17 |
| 37458 | SUPPL | 2014-11-25 |
| 37457 | SUPPL | 2014-11-25 |
| 15985 | SUPPL | 2014-11-25 |
| 28376 | SUPPL | 2014-11-24 |
| 5986 | SUPPL | 2014-11-24 |
| 5985 | SUPPL | 2014-11-24 |
| 37456 | SUPPL | 2011-08-12 |
| 5984 | SUPPL | 2011-08-03 |
| 37455 | SUPPL | 2011-03-04 |
| 5983 | SUPPL | 2011-03-02 |
| 28375 | SUPPL | 2010-01-21 |
| 37454 | SUPPL | 2009-11-16 |
| 37453 | SUPPL | 2009-01-06 |
| 28374 | SUPPL | 2008-12-29 |
| 5982 | SUPPL | 2008-05-07 |
| 15984 | SUPPL | 2008-03-05 |
| 5981 | SUPPL | 2008-03-04 |
| 37452 | SUPPL | 2007-10-10 |
| 28373 | SUPPL | 2007-10-10 |
| 21779 | ORIG | 2004-05-10 |
| 15983 | ORIG | 2004-04-05 |
| 5980 | ORIG | 2004-03-10 |
| 52569 | SUPPL | 1900-01-01 |
| 52568 | SUPPL | 1900-01-01 |
| 52567 | SUPPL | 1900-01-01 |
| 52566 | SUPPL | 1900-01-01 |