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FDA ANDA · ANDA077926

CARBOPLATIN

Sponsor: SUN PHARM

APPLICATION
ANDA077926
TYPE
ANDA
ORIGINAL APPROVAL
2008-09-19
LATEST ACTION
2014-12-12
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

Approval history

2014-12-12Labeling · Supplement 4 · standardAP
2014-02-18Manufacturing (CMC) · Supplement 1AP
2008-09-19OriginalAP
VIEW ON DRUGS@FDA ↗

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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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