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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207873

MESALAMINE (MESALAMINE)
400MG
Marketing Status: Prescription
Active Ingredient: MESALAMINE
Proprietary Name: MESALAMINE
Dosage Form; Route of Administration: CAPSULE, DELAYED RELEASE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207873
Product Number: 001
Approval Date: May 9, 2019
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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