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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217865

DUVYZAT (GIVINOSTAT HYDROCHLORIDE)
EQ 8.86MG BASE/ML
Marketing Status: Prescription
Active Ingredient: GIVINOSTAT HYDROCHLORIDE
Proprietary Name: DUVYZAT
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: EQ 8.86MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217865
Product Number: 001
Approval Date: Mar 21, 2024
Applicant Holder Full Name: ITALFARMACO SPA
Marketing Status:  Prescription
Patent and Exclusivity Information
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