Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091640

MESALAMINE (MESALAMINE)
1.2GM Marketing Status: Prescription

Active Ingredient: MESALAMINE
Proprietary Name: MESALAMINE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 1.2GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091640
Product Number: 001
Approval Date: Jun 5, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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