Docetaxel

Treats operable node-positive BC Non-Small Cell Lung Cancer (NSCLC). NDA 203551, held by Actavis. Docetaxel.

As of Nov 14, 2026, NDA 203551 (Docetaxel), held by Actavis, was first approved by FDA on Apr 12, 2013, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 12, 2013
Review: Standard
Supplements approved: 8
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 junction…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 12, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

4 strengths and forms


Docetaxel20MG/ML (20MG/ML) · injectable;injection	Docetaxel	Rx
Docetaxel80MG/4ML (20MG/ML) · injectable;injection	Docetaxel	Rx
Docetaxel140MG/7ML (20MG/ML) · injectable;injection	Docetaxel	Rx
Docetaxel160MG/8ML (20MG/ML) · injectable;injection	Docetaxel	Rx

All 9 submissions, including labeling and manufacturing supplements


Aug 26, 2024	Supplement 12Labeling · Standard review	Approved	Letter Label
Jul 27, 2020	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 9, 2019	Supplement 7Labeling · Standard review	Approved	Letter Label
Apr 11, 2018	Supplement 5Labeling · Standard review	Approved	Letter Label
Sep 21, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 7, 2015	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 17, 2014	Supplement 2Labeling · Standard review	Approved	Letter Label
Nov 4, 2013	Supplement 1Labeling · Standard review	Approved	Letter Label
Apr 12, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 203551
Drugs@FDA: Overview at FDA
Company: Actavis

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