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FDA NDA · NDA211875

PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND

paclitaxel

Sponsor: AM REGENT

APPLICATION
NDA211875
TYPE
NDA
ORIGINAL APPROVAL
2022-07-27
LATEST ACTION
2022-07-27
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

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

Approval history

2022-07-27Type 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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