APPLICATION
ANDA077244
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-15
LATEST ACTION
2012-03-13
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CARBOPLATINPrescription
CARBOPLATIN 150MG/15ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 450MG/45ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 50MG/5ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 600MG/60ML (10MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2012-03-13Labeling · Supplement 10AP
2011-09-07Labeling · Supplement 8AP
2006-01-20Labeling · Supplement 3AP
2006-01-20Manufacturing (CMC) · Supplement 2AP
2005-07-11Labeling · Supplement 1AP
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.
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