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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212327

INREBIC (FEDRATINIB HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: FEDRATINIB HYDROCHLORIDE
Proprietary Name: INREBIC
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212327
Product Number: 001
Approval Date: Aug 16, 2019
Applicant Holder Full Name: IMPACT BIOMEDICINES INC A WHOLLY OWNED SUB OF CELGENE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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