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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021324

ENTOCORT EC (BUDESONIDE)
3MG
Marketing Status: Prescription
Active Ingredient: BUDESONIDE
Proprietary Name: ENTOCORT EC
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021324
Product Number: 001
Approval Date: Oct 2, 2001
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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