Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218944

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REVUFORJ (REVUMENIB CITRATE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: REVUMENIB CITRATE
Proprietary Name: REVUFORJ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218944
Product Number: 001
Approval Date: Nov 15, 2024
Applicant Holder Full Name: SYNDAX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

REVUFORJ (REVUMENIB CITRATE)
EQ 110MG BASE
Marketing Status: Prescription

Active Ingredient: REVUMENIB CITRATE
Proprietary Name: REVUFORJ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 110MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218944
Product Number: 002
Approval Date: Nov 15, 2024
Applicant Holder Full Name: SYNDAX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

REVUFORJ (REVUMENIB CITRATE)
EQ 160MG BASE
Marketing Status: Prescription

Active Ingredient: REVUMENIB CITRATE
Proprietary Name: REVUFORJ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 160MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218944
Product Number: 003
Approval Date: Nov 15, 2024
Applicant Holder Full Name: SYNDAX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information