APPLICATION
ANDA204193
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-05
LATEST ACTION
2022-01-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOCETAXELPrescription
DOCETAXEL 80MG/4ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 20MG/ML (20MG/ML) · INJECTABLE · INJECTION
Approval history
2022-01-11Labeling · Supplement 11 · standardAP
2019-04-01Labeling · Supplement 6 · standardAP
2018-01-04Labeling · Supplement 4 · standardAP
2015-04-03Labeling · Supplement 3 · standardAP
2014-11-05UNKNOWN · OriginalAP
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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