Details for New Drug Application (NDA): 203551

NDA 203551 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 203551

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

Pharmacology for NDA: 203551

Physiological Effect

Microtubule Inhibition

Suppliers and Packaging for NDA: 203551

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	203551	NDA	Actavis Pharma, Inc.	45963-734	45963-734-54	1 VIAL, GLASS in 1 CARTON (45963-734-54) / 1 mL in 1 VIAL, GLASS
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	203551	NDA	Actavis Pharma, Inc.	45963-765	45963-765-52	1 VIAL, GLASS in 1 CARTON (45963-765-52) / 4 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML (20MG/ML)
Approval Date:	Apr 12, 2013	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/4ML (20MG/ML)
Approval Date:	Apr 12, 2013	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	140MG/7ML (20MG/ML)
Approval Date:	Apr 12, 2013	TE:		RLD:	No

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