Docetaxel

Treats operable node-positive BC. NDA 22234, held by Hospira Inc. Docetaxel.

As of Nov 15, 2026, NDA 22234 (Docetaxel), held by Hospira Inc, was first approved by FDA on Mar 8, 2011, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 8, 2011
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Docetaxel Injection is a microtubule inhibitor indicated for:

Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal …

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Jul 10, 2014	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 8, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

7 strengths and forms


Docetaxel20MG/2ML (10MG/ML) · injectable;injection	Docetaxel	RxReference drug
Docetaxel80MG/8ML (10MG/ML) · injectable;injection	Docetaxel	RxReference drug
Docetaxel160MG/16ML (10MG/ML) · injectable;injection	Docetaxel	RxReference drug
Docetaxel20MG/ML (20MG/ML) · injectable;injection	Docetaxel	RxReference drug
Docetaxel80MG/4ML (20MG/ML) · injectable;injection	Docetaxel	RxReference drug
Docetaxel120MG/6ML (20MG/ML) · injectable;injection	Docetaxel	DiscontinuedReference drug
Docetaxel160MG/8ML (20MG/ML) · injectable;injection	Docetaxel	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


May 15, 2023	Supplement 22Labeling · Standard review	Approved	Label Letter
Nov 24, 2020	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 11, 2019	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 11, 2019	Supplement 13Labeling · Standard review	Approved	Letter Label
Oct 11, 2019	Supplement 15Labeling · Standard review	Approved	Letter Label
Sep 24, 2018	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 2, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Sep 27, 2017	Supplement 8Labeling · Standard review	Approved	Letter Label
Jan 25, 2017	Supplement 5Manufacturing · Standard review	Approved	Label
Jun 24, 2016	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 10, 2014	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 23, 2014	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 8, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22234
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters