APPLICATION
ANDA077059
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-23
LATEST ACTION
2024-06-07
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CARBOPLATINPrescription
CARBOPLATIN 600MG/60ML (10MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2024-06-07Labeling · Supplement 24 · standardAP
2017-07-24Manufacturing (CMC) · Supplement 19AP
2005-06-07Labeling · Supplement 3AP
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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