APPLICATION
ANDA206125
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-08
LATEST ACTION
2026-03-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CINACALCET HYDROCHLORIDEPrescription
CINACALCET HYDROCHLORIDE EQ 90MG BASE · TABLET · ORAL
CINACALCET HYDROCHLORIDEPrescription
CINACALCET HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
CINACALCET HYDROCHLORIDEPrescription
CINACALCET HYDROCHLORIDE EQ 60MG BASE · TABLET · ORAL
Approval history
2026-03-23Manufacturing (CMC) · Supplement 10 · unknownAP
2023-07-28Labeling · Supplement 8 · standardAP
2020-12-04Labeling · Supplement 6 · standardAP
2020-12-04Labeling · Supplement 4 · standardAP
2020-05-14Labeling · Supplement 3 · standardAP
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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