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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215935

TARPEYO (BUDESONIDE)
4MG
Marketing Status: Prescription
Active Ingredient: BUDESONIDE
Proprietary Name: TARPEYO
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215935
Product Number: 001
Approval Date: Dec 15, 2021
Applicant Holder Full Name: CALLIDITAS THERAPEUTICS AB
Marketing Status:  Prescription
Patent and Exclusivity Information
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