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FDA ANDA · ANDA209403

CINACALCET

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA209403
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-07
LATEST ACTION
2020-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-10-07UNKNOWN · Original · standardAP
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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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