Details for New Drug Application (NDA): 205934

NDA 205934 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 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 suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 205934

Tradename:	DOCETAXEL
Applicant:	Shilpa
Ingredient:	docetaxel
Patents:	4

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML (20MG/ML)
Approval Date:	Dec 22, 2015	TE:	AP	RLD:	Yes
Patent:		Patent Expiration:	Aug 7, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF ADMINISTERING DOCETAXEL TO A SUBJECT COMBINING THE DOCETAXEL PRO-EMULSION FORMULATION WITH AN AQUEOUS MEDIUM TO PRODUCE DOCETAXEL EMULSION
Patent:		Patent Expiration:	Sep 30, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION
Patent:		Patent Expiration:	Sep 30, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

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