APPLICATION
ANDA207563
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-31
LATEST ACTION
2025-02-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOCETAXELDiscontinued
DOCETAXEL 80MG/8ML (10MG/ML) · INJECTABLE · INJECTION
DOCETAXELDiscontinued
DOCETAXEL 160MG/16ML (10MG/ML) · INJECTABLE · INJECTION
DOCETAXELDiscontinued
DOCETAXEL 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2025-02-28Labeling · Supplement 11 · standardAP
2020-09-23Labeling · Supplement 5 · standardAP
2019-09-06Labeling · Supplement 4 · standardAP
2019-09-06Labeling · Supplement 2 · 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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