← FDA DRUG APPROVALS

FDA NDA · NDA215000

CARMUSTINE

Sponsor: ACCORD HLTHCARE

APPLICATION
NDA215000
TYPE
NDA
ORIGINAL APPROVAL
2022-05-16
LATEST ACTION
2022-05-16
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

CARMUSTINE · ReferenceDiscontinued
CARMUSTINE 50MG/VIAL · POWDER · INTRAVENOUS
CARMUSTINE · ReferenceDiscontinued
CARMUSTINE 300MG/VIAL · POWDER · INTRAVENOUS

Approval history

2022-05-16Type 2 - New Active Ingredient · Original · standard — Letter ↗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 →