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FDA NDA · NDA201195

DOCETAXEL

Sponsor: ACCORD HLTHCARE

APPLICATION
NDA201195
TYPE
NDA
ORIGINAL APPROVAL
2011-06-08
LATEST ACTION
2023-09-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

DOCETAXEL · ReferencePrescription
DOCETAXEL 160MG/8ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferencePrescription
DOCETAXEL 20MG/ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferenceDiscontinued
DOCETAXEL 20MG/0.5ML (40MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferencePrescription
DOCETAXEL 80MG/4ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferenceDiscontinued
DOCETAXEL 80MG/2ML (40MG/ML) · INJECTABLE · INJECTION

Approval history

2023-09-20Labeling · Supplement 19 · standard — Letter ↗AP
2020-07-20Labeling · Supplement 15 · standard — Letter ↗AP
2019-06-21Labeling · Supplement 13 · standard — Letter ↗AP
2016-07-26Labeling · Supplement 9 · standard — Label ↗AP
2016-05-27Manufacturing (CMC) · Supplement 7 · standardAP
2015-10-21Manufacturing (CMC) · Supplement 8 · standardAP
2014-07-03Labeling · Supplement 6 · standard — Letter ↗AP
2013-11-06Manufacturing (CMC) · Supplement 5 · standardAP
2013-04-05Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2011-06-08Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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