Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209606

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IDHIFA (ENASIDENIB MESYLATE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: ENASIDENIB MESYLATE
Proprietary Name: IDHIFA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209606
Product Number: 001
Approval Date: Aug 1, 2017
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Prescription
Patent and Exclusivity Information

IDHIFA (ENASIDENIB MESYLATE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: ENASIDENIB MESYLATE
Proprietary Name: IDHIFA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209606
Product Number: 002
Approval Date: Aug 1, 2017
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Prescription
Patent and Exclusivity Information