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FDA NDA · NDA022312

DOCETAXEL

Sponsor: APOTEX INC

APPLICATION
NDA022312
TYPE
NDA
ORIGINAL APPROVAL
2012-01-11
LATEST ACTION
2012-01-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DOCETAXELDiscontinued
DOCETAXEL 20MG/0.5ML (40MG/ML) · INJECTABLE · INJECTION
DOCETAXELDiscontinued
DOCETAXEL 80MG/2ML (40MG/ML) · INJECTABLE · INJECTION

Approval history

2012-01-11Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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