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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 three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TARCEVA profile page.

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

Summary for NDA: 021743

Osi Pharms
erlotinib hydrochloride
Therapeutic Class:Antineoplastics

Pharmacology for NDA: 021743

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 021743

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 18, 2004TE:RLD:No
Regulatory Exclusivity Expiration:Jun 1, 2019
Regulatory Exclusivity Use:
Patent:5,747,498*PEDPatent Expiration:May 8, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,900,221*PEDPatent Expiration:May 9, 2021Product Flag?Substance Flag?Delist Request?Y

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