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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212576

INQOVI (CEDAZURIDINE; DECITABINE)
100MG;35MG
Marketing Status: Prescription
Active Ingredient: CEDAZURIDINE; DECITABINE
Proprietary Name: INQOVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG;35MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212576
Product Number: 001
Approval Date: Jul 7, 2020
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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