APPLICATION
ANDA215744
TYPE
ANDA
ORIGINAL APPROVAL
2023-02-28
LATEST ACTION
2023-07-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOCETAXELPrescription
DOCETAXEL 80MG/8ML (10MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 160MG/16ML (10MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2023-07-12Labeling · Supplement 2 · standardAP
2023-02-28UNKNOWN · 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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