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Last Updated: December 21, 2024

Details for New Drug Application (NDA): 203170

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NDA 203170 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hengrui Pharma, Heritage, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Pfizer Labs, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa, and is included in twenty-seven 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-three suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 203170

Tradename:	DOCETAXEL
Applicant:	Hengrui Pharma
Ingredient:	docetaxel
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Feb 15, 2017	TE:		RLD:	No

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