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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 219616

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) (AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE)
EQ 0.8MG BASE;EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
Proprietary Name: AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)
Dosage Form; Route of Administration: CAPSULE, TABLET; ORAL
Strength: EQ 0.8MG BASE;EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N219616
Product Number: 001
Approval Date: May 8, 2025
Applicant Holder Full Name: VERASTEM INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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