APPLICATION
ANDA077269
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-14
LATEST ACTION
2012-03-26
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 600MG/60ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 150MG/15ML (10MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2012-03-26Labeling · Supplement 8AP
2007-12-28Labeling · Supplement 2AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.