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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216718

SKYCLARYS (OMAVELOXOLONE)
50MG
Marketing Status: Prescription
Active Ingredient: OMAVELOXOLONE
Proprietary Name: SKYCLARYS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216718
Product Number: 001
Approval Date: Feb 28, 2023
Applicant Holder Full Name: REATA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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