APPLICATION
ANDA077861
TYPE
ANDA
ORIGINAL APPROVAL
2007-01-18
LATEST ACTION
2023-06-16
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CARBOPLATINPrescription
CARBOPLATIN 50MG/5ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 600MG/60ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 150MG/15ML (10MG/ML) · INJECTABLE · INTRAVENOUS
CARBOPLATINPrescription
CARBOPLATIN 450MG/45ML (10MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2023-06-16Manufacturing (CMC) · Supplement 2 · unknownAP
2020-03-05Labeling · Supplement 1 · standardAP
2007-01-18OriginalAP
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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