Docetaxel

Treats operable node-positive BC Non-small Cell Lung Cancer (NSCLC). ANDA 204193, held by Dr Reddys. Docetaxel.

As of Nov 15, 2026, ANDA 204193 (Docetaxel), held by Dr Reddys, was first approved by FDA on Nov 5, 2014, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 5, 2014
Supplements approved: 6
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 7 submissions below

Date	Submission	Status	Documents
Nov 5, 2014	Original application	Approved	None posted

Products

2 strengths and forms


Docetaxel20MG/ML (20MG/ML) · injectable;injection	Docetaxel	Rx
Docetaxel80MG/4ML (20MG/ML) · injectable;injection	Docetaxel	Rx

All 7 submissions, including labeling and manufacturing supplements


Jan 11, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Jan 11, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jan 11, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Apr 1, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Jan 4, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Apr 3, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Nov 5, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 204193
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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