Docefrez, Docetaxel

Treats operable node-positive BC Non-small Cell Lung Cancer (NSCLC). NDA 22534, held by Sun Pharm. Docetaxel.

As of Nov 14, 2026, NDA 22534 (Docefrez, Docetaxel), held by Sun Pharm, was first approved by FDA on May 3, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: May 3, 2011
Review: Standard
Supplements approved: 10
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 11 submissions below


Jan 8, 2019	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 3, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

5 strengths and forms


Docefrez20MG/VIAL · injectable;injection	Docetaxel	DiscontinuedReference drug
Docefrez80MG/VIAL · injectable;injection	Docetaxel	DiscontinuedReference drug
Docetaxel20MG/ML (20MG/ML) · injectable;injection	Docetaxel	Discontinued
Docetaxel80MG/4ML (20MG/ML) · injectable;injection	Docetaxel	Discontinued
Docetaxel160MG/8ML (20MG/ML) · injectable;injection	Docetaxel	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Aug 22, 2023	Supplement 17Labeling · Standard review	Approved	Label Letter
Dec 9, 2022	Supplement 16Labeling · Standard review	Approved	Label Letter
Feb 1, 2021	Supplement 12Labeling · Standard review	Approved	Label Letter
Feb 25, 2020	Supplement 11Labeling · Standard review	Approved	Letter Label
Jan 8, 2019	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 5, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 30, 2014	Supplement 4Labeling · Standard review	Approved	Label Letter
Jun 21, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 13, 2012	Supplement 2Labeling	Approved	Label Letter
May 3, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22534
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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