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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 202356

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NDA 202356 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-one 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-five suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 202356

Tradename:	DOCETAXEL
Applicant:	Pfizer Labs
Ingredient:	docetaxel
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/2ML (10MG/ML)
Approval Date:	Mar 13, 2014	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	80MG/8ML (10MG/ML)
Approval Date:	Mar 13, 2014	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	130MG/13ML (10MG/ML)
Approval Date:	Mar 13, 2014	TE:		RLD:	No

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