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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019919

ROWASA (MESALAMINE)
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MESALAMINE
Proprietary Name: ROWASA
Dosage Form; Route of Administration: SUPPOSITORY; RECTAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019919
Product Number: 001
Approval Date: Dec 18, 1990
Applicant Holder Full Name: MEDA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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