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FDA NDA · NDA022534

DOCETAXEL

Sponsor: SUN PHARM

APPLICATION
NDA022534
TYPE
NDA
ORIGINAL APPROVAL
2011-05-03
LATEST ACTION
2023-08-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DOCETAXELDiscontinued
DOCETAXEL 160MG/8ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXELDiscontinued
DOCETAXEL 20MG/ML (20MG/ML) · INJECTABLE · INJECTION
DOCEFREZ · ReferenceDiscontinued
DOCETAXEL 20MG/VIAL · INJECTABLE · INJECTION
DOCETAXELDiscontinued
DOCETAXEL 80MG/4ML (20MG/ML) · INJECTABLE · INJECTION
DOCEFREZ · ReferenceDiscontinued
DOCETAXEL 80MG/VIAL · INJECTABLE · INJECTION

Approval history

2023-08-22Labeling · Supplement 17 · standard — Letter ↗AP
2022-12-09Labeling · Supplement 16 · standard — Label ↗AP
2021-02-01Labeling · Supplement 12 · standard — Letter ↗AP
2020-02-25Labeling · Supplement 11 · standard — Letter ↗AP
2019-01-08Efficacy · Supplement 7 · standard — Label ↗AP
2015-05-05Manufacturing (CMC) · Supplement 6 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 5 · standardAP
2014-10-30Labeling · Supplement 4 · standard — Label ↗AP
2013-06-21Manufacturing (CMC) · Supplement 3 · standardAP
2012-07-13Labeling · Supplement 2 · unknown — Label ↗AP
2011-05-03Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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