APPLICATION
ANDA210327
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-16
LATEST ACTION
2024-03-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOCETAXELPrescription
DOCETAXEL 80MG/4ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 160MG/8ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 20MG/ML (20MG/ML) · INJECTABLE · INJECTION
Approval history
2024-03-19Labeling · Supplement 4 · standardAP
2020-09-28Labeling · Supplement 2 · standardAP
2020-09-28Labeling · Supplement 3 · standardAP
2020-09-28Labeling · Supplement 1 · standardAP
2019-05-16UNKNOWN · 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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