← FDA DRUG APPROVALS

FDA ANDA · ANDA210548

CINACALCET HYDROCHLORIDE

Sponsor: LUPIN

APPLICATION
ANDA210548
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-28
LATEST ACTION
2020-12-04
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

2020-12-04Labeling · Supplement 1 · standardAP
2019-06-28UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →