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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022301

APRISO (MESALAMINE)
375MG
Marketing Status: Prescription
Active Ingredient: MESALAMINE
Proprietary Name: APRISO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 375MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022301
Product Number: 001
Approval Date: Oct 31, 2008
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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