Docetaxel

Treats operable node-positive BC Non-small Cell Lung Cancer (NSCLC). NDA 201195, held by Accord Hlthcare. Docetaxel.

As of Nov 15, 2026, NDA 201195 (Docetaxel), held by Accord Hlthcare, was first approved by FDA on Jun 8, 2011, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 8, 2011
Review: Standard
Supplements approved: 9
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 10 submissions below

Date	Submission	Status	Documents
Jun 8, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Letter Label

Products

5 strengths and forms


Docetaxel20MG/0.5ML (40MG/ML) · injectable;injection	Docetaxel	DiscontinuedReference drug
Docetaxel80MG/2ML (40MG/ML) · injectable;injection	Docetaxel	DiscontinuedReference drug
Docetaxel20MG/ML (20MG/ML) · injectable;injection	Docetaxel	RxReference drug
Docetaxel80MG/4ML (20MG/ML) · injectable;injection	Docetaxel	RxReference drug
Docetaxel160MG/8ML (20MG/ML) · injectable;injection	Docetaxel	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Sep 20, 2023	Supplement 19Labeling · Standard review	Approved	Letter Label
Jul 20, 2020	Supplement 15Labeling · Standard review	Approved	Label Letter
Jun 21, 2019	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 26, 2016	Supplement 9Labeling · Standard review	Approved	Letter Label
May 27, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 21, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 3, 2014	Supplement 6Labeling · Standard review	Approved	Letter Label
Nov 6, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 5, 2013	Supplement 4Manufacturing · Standard review	Approved	Label
Jun 8, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 201195
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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