mesalamine
mesalamine is listed in the FDA National Drug Code directory with 23 NDC codes, marketed under brand names including mesalamine, Rowasa, MESALAMINE. Available dosage forms: tablet, delayed release, suspension, capsule, extended release, capsule.
Drug Details
- Generic Name
- mesalamine
- Brand Names
- mesalamine, Rowasa, MESALAMINE, Mesalamine, APRISO, Pentasa, Lialda, sfRowasa Sulfite-Free Formulation
- Application Number
- ANDA203286
- Sponsor
- Zydus Pharmaceuticals USA Inc.
- NDC Codes
- 23
- Dosage Forms
- TABLET, DELAYED RELEASE, SUSPENSION, CAPSULE, EXTENDED RELEASE, CAPSULE
- Routes
- ORAL, RECTAL
- Active Ingredients
- MESALAMINE
Indications and Usage
1 INDICATIONS AND USAGE ROWASA is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ROWASA is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ( 1 )