APPLICATION
ANDA212700
TYPE
ANDA
ORIGINAL APPROVAL
2024-10-08
LATEST ACTION
2025-07-10
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
PACLITAXELPrescription
PACLITAXEL 100MG/VIAL · POWDER · INTRAVENOUS
Approval history
2025-07-10Labeling · Supplement 4 · standardAP
2024-10-08UNKNOWN · Original · standardAP
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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