Docetaxel

ANDA 203170, held by Hengrui Pharma. Docetaxel.

As of Nov 15, 2026, ANDA 203170 (Docetaxel), held by Hengrui Pharma, was first approved by FDA on Feb 15, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 15, 2017
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 15, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Docetaxel40MG/ML · injectable;injection	Docetaxel	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 4, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 4, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Oct 28, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Oct 28, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Feb 15, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 203170
Drugs@FDA: Overview at FDA
Company: Hengrui 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