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Active ingredient

Docetaxel

70 finished FDA listings contain Docetaxel as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DOCETAXEL, DOCETAXEL ANHYDROUS
Dosage forms
Injection, Injection, Solution, Injection, Solution, Concentrate
Routes
Intravenous
Manufacturers / labelers
23
Strengths listed
10 mg/ml · 160 mg/16ml · 160 mg/8ml · 20 mg/2ml · 20 mg/ml · 80 mg/4ml · 80 mg/8ml
Brand names in FDA listings
Beizray, Docetaxel, Docivyx

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 72962

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020449SANOFI AVENTIS US1996-05-143
NDA 022234HOSPIRA INC2011-03-0811
NDA 022534SUN PHARM2011-05-033
NDA 201195ACCORD HLTHCARE2011-06-081
NDA 201525SANDOZ2011-06-294
NDA 203551ACTAVIS2013-04-122
ANDA 204193DR REDDYS2014-11-055
ANDA 207252HENGRUI PHARMA2017-08-094
ANDA 209640AMNEAL2018-01-193
ANDA 208859MYLAN LABS LTD2018-04-302
ANDA 210072MYLAN LABS LTD2018-07-022
ANDA 210848MYLAN LABS LTD2018-07-062
ANDA 209634MEITHEAL2018-08-241
ANDA 208137MYLAN LABS LTD2019-04-011
ANDA 204490HIKMA2021-01-142
ANDA 214575EUGIA PHARMA2021-06-253
ANDA 213510GLAND2021-07-014
NDA 215813AVYXA HOLDINGS2022-11-223
ANDA 215744ALEMBIC2023-02-285
ANDA 216677HERITAGE2024-02-283
NDA 218711ZHUHAI2024-10-234
ANDA 213768GUANGDONG SUNHO2025-05-132

Official labeling on DailyMed

Showing the 12 most recent of 31 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.