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FDA ANDA · ANDA076099

CARBOPLATIN

Sponsor: HIKMA

APPLICATION
ANDA076099
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-14
LATEST ACTION
2012-03-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CARBOPLATINDiscontinued
CARBOPLATIN 450MG/VIAL · INJECTABLE · INJECTION
CARBOPLATINDiscontinued
CARBOPLATIN 50MG/VIAL · INJECTABLE · INJECTION
CARBOPLATINDiscontinued
CARBOPLATIN 150MG/VIAL · INJECTABLE · INJECTION

Approval history

2012-03-02Labeling · Supplement 6AP
2011-09-07Labeling · Supplement 4AP
2004-10-14OriginalAP
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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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