U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 206995

IRESSA (GEFITINIB)
250MG
Marketing Status: Prescription
Active Ingredient: GEFITINIB
Proprietary Name: IRESSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N206995
Product Number: 001
Approval Date: Jul 13, 2015
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top