APPLICATION
ANDA075184
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-25
LATEST ACTION
2015-04-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PACLITAXELPrescription
PACLITAXEL 6MG/ML · INJECTABLE · INJECTION
Approval history
2015-04-10Labeling · Supplement 16AP
2012-03-28Labeling · Supplement 14AP
2008-09-10Labeling · Supplement 10AP
2008-05-20Labeling · Supplement 9AP
2002-10-23Manufacturing (CMC) · Supplement 1AP
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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