← FDA DRUG APPROVALS

FDA ANDA · ANDA210984

DECITABINE

Sponsor: INGENUS PHARMS LLC

APPLICATION
ANDA210984
TYPE
ANDA
ORIGINAL APPROVAL
2019-09-16
LATEST ACTION
2021-03-17
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DECITABINEDiscontinued
DECITABINE 50MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2021-03-17Labeling · Supplement 4 · standardAP
2021-03-17Labeling · Supplement 2 · standardAP
2019-09-16UNKNOWN · Original · standardAP
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 →