← FDA DRUG APPROVALS

FDA NDA · NDA204820

MITIGARE

colchicine

Sponsor: HIKMA INTL PHARMS

APPLICATION
NDA204820
TYPE
NDA
ORIGINAL APPROVAL
2014-09-26
LATEST ACTION
2024-05-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MITIGARE · ReferencePrescription
COLCHICINE 0.6MG · CAPSULE · ORAL

Approval history

2024-05-16Labeling · Supplement 6 · standard — Label ↗AP
2018-11-16Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2014-09-26Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →