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FDA NDA · NDA203551

DOCETAXEL

Sponsor: ACTAVIS

APPLICATION
NDA203551
TYPE
NDA
ORIGINAL APPROVAL
2013-04-12
LATEST ACTION
2024-08-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DOCETAXELPrescription
DOCETAXEL 140MG/7ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 20MG/ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 160MG/8ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 80MG/4ML (20MG/ML) · INJECTABLE · INJECTION

Approval history

2024-08-26Labeling · Supplement 12 · standard — Letter ↗AP
2020-07-27Labeling · Supplement 9 · standard — Letter ↗AP
2019-07-09Labeling · Supplement 7 · standard — Letter ↗AP
2018-04-11Labeling · Supplement 5 · standard — Label ↗AP
2015-09-21Manufacturing (CMC) · Supplement 4 · standardAP
2015-04-07Manufacturing (CMC) · Supplement 3 · standardAP
2014-09-17Labeling · Supplement 2 · standard — Label ↗AP
2013-11-04Labeling · Supplement 1 · standard — Label ↗AP
2013-04-12Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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