Details for New Drug Application (NDA): 020449

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NDA 020449 describes TAXOTERE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the TAXOTERE profile page.

The generic ingredient in TAXOTERE 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 020449

Tradename:	TAXOTERE
Applicant:	Sanofi Aventis Us
Ingredient:	docetaxel
Patents:	0

Suppliers and Packaging for NDA: 020449

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449	NDA AUTHORIZED GENERIC	Sanofi-Aventis U.S. LLC	0955-1020	0955-1020-01	1 VIAL, GLASS in 1 CARTON (0955-1020-01) / 1 mL in 1 VIAL, GLASS
TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449	NDA AUTHORIZED GENERIC	Sanofi-Aventis U.S. LLC	0955-1021	0955-1021-04	1 VIAL, GLASS in 1 CARTON (0955-1021-04) / 4 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 14, 1996	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML (20MG/ML)
Approval Date:	Aug 3, 2010	TE:	AP	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/4ML (20MG/ML)
Approval Date:	Aug 2, 2010	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020449

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-001	May 14, 1996	5,750,561*PED	⤷ Subscribe
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-004	Aug 2, 2010	5,750,561*PED	⤷ Subscribe
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-001	May 14, 1996	4,814,470*PED	⤷ Subscribe
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-001	May 14, 1996	5,714,512*PED	⤷ Subscribe
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