Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Canasa (mesalamine) Suppositories, Axcan Scandipharm NDA 21-252/S2 10/14/03 10/17/03 Canasa (mesalamine) Suppositories, Axcan Scandipharm NDA 21-252 Pentasa (Mesalamine) Capsules Roberts NDA 20-049/S006 MESALAMINE Capsule, Extended Release; 250MG PENTASA SHIRE 019618 MESALAMINE Enema; Rectal 4GM/60ML ROWASA SOLVAY 021252 MESALAMINE Suppository; Rectal 500MG CANASA AXCAN SCANDIPHARM 019651 MESALAMINE Tablet, Delayed Release; 400MG ASACOL PROCTER AND GAMBLE Pentasa (meslamine) Controlled Release Capsules, Shire Pharmaceutical, Control Supplement   For the latest approval information, locate this drug using this index.