← FDA DRUG APPROVALS

FDA NDA · NDA021688

SENSIPAR

cinacalcet hydrochloride

Sponsor: AMGEN

APPLICATION
NDA021688
TYPE
NDA
ORIGINAL APPROVAL
2004-03-08
LATEST ACTION
2019-12-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SENSIPAR · ReferenceDiscontinued
CINACALCET HYDROCHLORIDE EQ 90MG BASE · TABLET · ORAL
SENSIPAR · ReferenceDiscontinued
CINACALCET HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
SENSIPAR · ReferenceDiscontinued
CINACALCET HYDROCHLORIDE EQ 60MG BASE · TABLET · ORAL

Approval history

2019-12-05Labeling · Supplement 27 · standard — Letter ↗AP
2019-03-29Labeling · Supplement 26 · standard — Label ↗AP
2019-03-29Labeling · Supplement 25 · standard — Label ↗AP
2017-05-23Efficacy · Supplement 23 · standard — Letter ↗AP
2017-05-15Labeling · Supplement 24 · 901 required — Label ↗AP
2014-11-21Labeling · Supplement 22 · standard — Letter ↗AP
2014-11-21Labeling · Supplement 20 · standard — Label ↗AP
2014-11-21Efficacy · Supplement 21 · standard — Label ↗AP
2011-08-01Labeling · Supplement 17 · unknown — Label ↗AP
2011-02-25Efficacy · Supplement 15 · standard — Letter ↗AP
2009-11-12Labeling · Supplement 13 · standard — Letter ↗AP
2008-12-19Labeling · Supplement 11 · standard — Letter ↗AP
2008-05-02Labeling · Supplement 9 · standard — Letter ↗AP
2008-02-28Labeling · Supplement 8 · standard — Letter ↗AP
2007-10-04Labeling · Supplement 6 · standard — Label ↗AP
2004-03-08Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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