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FDA ANDA · ANDA209226

CINACALCET

Sponsor: STRIDES PHARMA

APPLICATION
ANDA209226
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-30
LATEST ACTION
2020-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2020-05-18Labeling · Supplement 4 · standardAP
2020-05-18Labeling · Supplement 3 · standardAP
2018-04-30UNKNOWN · Original · standardAP
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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