APPLICATION
ANDA204377
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-27
LATEST ACTION
2018-12-27
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
2018-12-27UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.