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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 206995

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NDA 206995 describes IRESSA, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. Additional details are available on the IRESSA profile page.

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gefitinib profile page.
Summary for 206995
Formulation / Manufacturing:see details
Pharmacology for NDA: 206995
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 206995
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRESSA gefitinib TABLET;ORAL 206995 NDA AstraZeneca Pharmaceuticals LP 0310-0482 0310-0482-30 30 TABLET, COATED in 1 BOTTLE (0310-0482-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 13, 2015TE:ABRLD:Yes

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