Details for New Drug Application (NDA): 022534

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NDA 022534 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Acic Pharms, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hengrui Pharma, 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-one suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Physiological Effect	Microtubule Inhibition

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534	NDA	Sun Pharmaceutical Industries, Inc.	47335-323	47335-323-40	1 VIAL, GLASS in 1 CARTON (47335-323-40) / 1 mL in 1 VIAL, GLASS
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	022534	NDA	Sun Pharmaceutical Industries, Inc.	47335-323	47335-323-40	1 VIAL, GLASS in 1 CARTON (47335-323-40) / 1 mL in 1 VIAL, GLASS

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/VIAL
Approval Date:	May 3, 2011	TE:		RLD:	Yes

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	80MG/VIAL
Approval Date:	May 3, 2011	TE:		RLD:	Yes

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

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