Docetaxel

Treats operable node-positive BC Non-small Cell Lung Cancer (NSCLC). ANDA 209634, held by Meitheal. Docetaxel.

As of Nov 15, 2026, ANDA 209634 (Docetaxel), held by Meitheal, was first approved by FDA on Aug 24, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 24, 2018
Review: Standard
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Aug 24, 2018	Original application	Approved	None posted

Products

3 strengths and forms


Docetaxel20MG/2ML (10MG/ML) · injectable;injection	Docetaxel	Rx
Docetaxel80MG/8ML (10MG/ML) · injectable;injection	Docetaxel	Rx
Docetaxel160MG/16ML (10MG/ML) · injectable;injection	Docetaxel	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 15, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Dec 13, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Mar 13, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Aug 24, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209634
Drugs@FDA: Overview at FDA
Company: Meitheal Pharmaceuticals

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