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Last Updated: April 3, 2026

Details for New Drug Application (NDA): 208137

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NDA 208137 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland, Guangdong Sunho, Hengrui Pharma, Heritage, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Novast Labs, Pfizer Labs, Pharmobedient, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa, and is included in twenty-eight NDAs. It is available from twenty suppliers. There are four patents protecting this drug. Additional details are available on the DOCETAXEL profile page.

The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 208137

Tradename:	DOCETAXEL
Applicant:	Mylan Labs Ltd
Ingredient:	docetaxel
Patents:	0

Pharmacology for NDA: 208137

Physiological Effect	Microtubule Inhibition

Suppliers and Packaging for NDA: 208137

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	208137	ANDA	Mylan Institutional LLC	67457-781	67457-781-08	1 VIAL, MULTI-DOSE in 1 CARTON (67457-781-08) / 8 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	160MG/8ML (20MG/ML)
Approval Date:	Apr 1, 2019	TE:	AP	RLD:	No

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