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 219379

GOMEKLI (MIRDAMETINIB)
1MG
Marketing Status: Prescription
Active Ingredient: MIRDAMETINIB
Proprietary Name: GOMEKLI
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N219379
Product Number: 001
Approval Date: Feb 11, 2025
Applicant Holder Full Name: SPRINGWORKS THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top