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FDA ANDA · ANDA075190

PACLITAXEL

Sponsor: HIKMA

APPLICATION
ANDA075190
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-28
LATEST ACTION
2011-12-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PACLITAXELPrescription
PACLITAXEL 6MG/ML · INJECTABLE · INJECTION

Approval history

2011-12-02Labeling · Supplement 9AP
2011-11-28Labeling · Supplement 11AP
2005-04-20Labeling · Supplement 4AP
2002-01-28OriginalLetterAP
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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