Docetaxel

ANDA 203877, held by Teva Pharms USA. Docetaxel.

As of Nov 15, 2026, ANDA 203877 (Docetaxel), held by Teva Pharms USA, was first approved by FDA on Sep 16, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 16, 2015
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 16, 2015	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jul 28, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Sep 16, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203877
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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