APPLICATION
ANDA208859
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-30
LATEST ACTION
2024-02-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOCETAXELPrescription
DOCETAXEL 160MG/16ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2024-02-23Labeling · Supplement 9 · standardAP
2024-02-23Labeling · Supplement 7 · standardAP
2020-09-23Labeling · Supplement 4 · standardAP
2019-09-05Labeling · Supplement 2 · standardAP
2018-04-30UNKNOWN · 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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