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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 219389

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GOMEKLI (MIRDAMETINIB)
1MG
Marketing Status: Prescription
Active Ingredient: MIRDAMETINIB
Proprietary Name: GOMEKLI
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N219389
Product Number: 001
Approval Date: Feb 11, 2025
Applicant Holder Full Name: SPRINGWORKS THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GOMEKLI (MIRDAMETINIB)
2MG
Marketing Status: Prescription
Active Ingredient: MIRDAMETINIB
Proprietary Name: GOMEKLI
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N219389
Product Number: 002
Approval Date: Feb 11, 2025
Applicant Holder Full Name: SPRINGWORKS THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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