FDA NDA · NDA202356

DOCETAXEL

Sponsor: PFIZER LABS

APPLICATION

NDA202356

TYPE

NDA

ORIGINAL APPROVAL

2014-03-13

LATEST ACTION

2018-09-24

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

DOCETAXELDiscontinued

DOCETAXEL 200MG/20ML (10MG/ML) · INJECTABLE · INJECTION

DOCETAXELDiscontinued

DOCETAXEL 80MG/8ML (10MG/ML) · INJECTABLE · INJECTION

DOCETAXELDiscontinued

DOCETAXEL 130MG/13ML (10MG/ML) · INJECTABLE · INJECTION

DOCETAXELDiscontinued

DOCETAXEL 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION

2018-09-24Labeling · Supplement 3 · standard — Label ↗AP

2017-11-21Labeling · Supplement 2 · standard — Label ↗AP

2014-12-02Manufacturing (CMC) · Supplement 1 · standardAP

2014-03-13Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP

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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