APPLICATION
ANDA076131
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-08
LATEST ACTION
2023-06-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PACLITAXELPrescription
PACLITAXEL 6MG/ML · INJECTABLE · INJECTION
Approval history
2023-06-05Manufacturing (CMC) · Supplement 30 · unknownAP
2007-03-23Labeling · Supplement 12AP
2007-03-07Labeling · Supplement 9AP
2002-05-08OriginalAP
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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