APPLICATION
ANDA210072
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-02
LATEST ACTION
2024-01-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOCETAXELPrescription
DOCETAXEL 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2024-01-12Labeling · Supplement 8 · standardAP
2024-01-12Labeling · Supplement 10 · standardAP
2020-09-10Labeling · Supplement 5 · standardAP
2019-09-05Labeling · Supplement 3 · standardAP
2018-07-02UNKNOWN · 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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