← FDA DRUG APPROVALS

FDA ANDA · ANDA090475

CARBOPLATIN

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA090475
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-29
LATEST ACTION
2009-07-29
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CARBOPLATINPrescription
CARBOPLATIN 450MG/45ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 50MG/5ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 150MG/15ML (10MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2009-07-29OriginalAP
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 →