APPLICATION
ANDA209640
TYPE
ANDA
ORIGINAL APPROVAL
2018-01-19
LATEST ACTION
2023-09-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOCETAXELPrescription
DOCETAXEL 20MG/ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 80MG/4ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 160MG/8ML (20MG/ML) · INJECTABLE · INJECTION
Approval history
2023-09-19Labeling · Supplement 9 · standardAP
2023-09-19Labeling · Supplement 3 · standardAP
2023-09-19Labeling · Supplement 1 · standardAP
2023-09-19Labeling · Supplement 4 · standardAP
2023-09-19Labeling · Supplement 2 · standardAP
2018-01-19UNKNOWN · 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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