← FDA DRUG APPROVALS

FDA NDA · NDA202497

MARQIBO KIT

Sponsor: ACROTECH

APPLICATION
NDA202497
TYPE
NDA
ORIGINAL APPROVAL
2012-08-09
LATEST ACTION
2022-03-15
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE, LIPOSOMAL
MARKETING STATUS
Discontinued

Products

MARQIBO KIT · ReferenceDiscontinued
VINCRISTINE SULFATE 5MG/5ML (1MG/ML) · INJECTABLE, LIPOSOMAL · INTRAVENOUS

Approval history

2022-03-15Labeling · Supplement 13 · standard — Letter ↗AP
2020-06-08Labeling · Supplement 11 · standard — Letter ↗AP
2020-01-03Labeling · Supplement 10 · standard — Label ↗AP
2016-11-30Manufacturing (CMC) · Supplement 5 · standardAP
2016-04-25Manufacturing (CMC) · Supplement 6 · standardAP
2015-10-06Manufacturing (CMC) · Supplement 4 · standardAP
2015-09-18Manufacturing (CMC) · Supplement 7 · standardAP
2014-11-03Manufacturing (CMC) · Supplement 3 · standardAP
2014-10-15Manufacturing (CMC) · Supplement 2 · standardAP
2014-07-07Manufacturing (CMC) · Supplement 1 · standardAP
2012-08-09Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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 →