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FDA NDA · NDA216338

PACLITAXEL

Sponsor: TEVA PHARMS INC

APPLICATION
NDA216338
TYPE
NDA
ORIGINAL APPROVAL
2023-05-11
LATEST ACTION
2023-11-21
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

PACLITAXEL · ReferencePrescription
PACLITAXEL 100MG/VIAL · POWDER · INTRAVENOUS

Approval history

2023-11-21Efficacy · Supplement 1 · standardLabelAP
2023-05-11Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
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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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