Details for New Drug Application (NDA): 201195

NDA 201195 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 201195

Tradename:	DOCETAXEL
Applicant:	Accord Hlthcare
Ingredient:	docetaxel
Patents:	0

Pharmacology for NDA: 201195

Physiological Effect

Microtubule Inhibition

Suppliers and Packaging for NDA: 201195

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	201195	NDA	Accord Healthcare Inc.	16729-267	16729-267-63	1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	201195	NDA	Accord Healthcare Inc.	16729-267	16729-267-64	1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/0.5ML (40MG/ML)
Approval Date:	Jun 8, 2011	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	80MG/2ML (40MG/ML)
Approval Date:	Jun 8, 2011	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML (20MG/ML)
Approval Date:	Apr 20, 2012	TE:	AP	RLD:	Yes

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