Last Updated: August 3, 2026

Details for New Drug Application (NDA): 210327

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NDA 210327 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, Ingenus Pharms Llc, Meitheal, Mylan Labs Ltd, Pfizer Labs, Pharmobedient, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa, and is included in twenty-eight NDAs. It is available from nineteen 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 210327

Tradename:	DOCETAXEL
Applicant:	Shilpa
Ingredient:	docetaxel
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML (20MG/ML)
Approval Date:	May 16, 2019	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/4ML (20MG/ML)
Approval Date:	May 16, 2019	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	160MG/8ML (20MG/ML)
Approval Date:	May 16, 2019	TE:	AP	RLD:	No

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