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FDA ANDA · ANDA204364

CINACALCET HYDROCHLORIDE

cinacalcet

Sponsor: STEVENS J

APPLICATION
ANDA204364
TYPE
ANDA
ORIGINAL APPROVAL
2021-12-02
LATEST ACTION
2021-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CINACALCET HYDROCHLORIDEDiscontinued
CINACALCET HYDROCHLORIDE EQ 90MG BASE · TABLET · ORAL
CINACALCET HYDROCHLORIDEDiscontinued
CINACALCET HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
CINACALCET HYDROCHLORIDEDiscontinued
CINACALCET HYDROCHLORIDE EQ 60MG BASE · TABLET · ORAL

Approval history

2021-12-02UNKNOWN · OriginalAP
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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