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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213312

Marketing Status: Prescription
Active Ingredient: SIROLIMUS
Proprietary Name: FYARRO
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 100MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213312
Product Number: 001
Approval Date: Nov 22, 2021
Applicant Holder Full Name: AADI BIOSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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