← FDA DRUG APPROVALS

FDA NDA · NDA022234

DOCETAXEL

Sponsor: HOSPIRA INC

APPLICATION
NDA022234
TYPE
NDA
ORIGINAL APPROVAL
2011-03-08
LATEST ACTION
2023-05-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

DOCETAXEL · ReferenceDiscontinued
DOCETAXEL 120MG/6ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferencePrescription
DOCETAXEL 20MG/ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferencePrescription
DOCETAXEL 80MG/8ML (10MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferencePrescription
DOCETAXEL 160MG/8ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferencePrescription
DOCETAXEL 80MG/4ML (20MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferencePrescription
DOCETAXEL 160MG/16ML (10MG/ML) · INJECTABLE · INJECTION
DOCETAXEL · ReferencePrescription
DOCETAXEL 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION

Approval history

2023-05-15Labeling · Supplement 22 · standard — Label ↗AP
2020-11-24Labeling · Supplement 18 · standard — Label ↗AP
2019-10-11Labeling · Supplement 12 · standard — Letter ↗AP
2019-10-11Labeling · Supplement 15 · standard — Letter ↗AP
2019-10-11Labeling · Supplement 13 · standard — Letter ↗AP
2018-09-24Labeling · Supplement 11 · standard — Label ↗AP
2018-08-02Labeling · Supplement 10 · standard — Letter ↗AP
2017-09-27Labeling · Supplement 8 · standard — Label ↗AP
2017-01-25Manufacturing (CMC) · Supplement 5 · standard — Label ↗AP
2016-06-24Manufacturing (CMC) · Supplement 4 · standardAP
2014-07-10Efficacy · Supplement 3 · standard — Label ↗AP
2014-01-23Manufacturing (CMC) · Supplement 2 · standardAP
2011-03-08Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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