Details for New Drug Application (NDA): 021743

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NDA 021743 describes TARCEVA, which is a drug marketed by Osi Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the TARCEVA profile page.

The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.

Summary for 021743

Tradename:	TARCEVA
Applicant:	Osi Pharms
Ingredient:	erlotinib hydrochloride
Patents:	0

Pharmacology for NDA: 021743

Mechanism of Action	Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for 021743

Antineoplastic Agents
Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 021743

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743	NDA	Genentech, Inc.	50242-062	50242-062-01	30 TABLET in 1 BOTTLE (50242-062-01)
TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743	NDA	Genentech, Inc.	50242-063	50242-063-01	30 TABLET in 1 BOTTLE (50242-063-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 18, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 18, 2004	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 18, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021743

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-003	Nov 18, 2004	⤷ Sign Up	⤷ Sign Up
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-001	Nov 18, 2004	⤷ Sign Up	⤷ Sign Up
Osi Pharms	TARCEVA	erlotinib hydrochloride	TABLET;ORAL	021743-002	Nov 18, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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