mesalamine

FDA Drug Profile — Pentasa, mesalamine, Lialda, Rowasa, MESALAMINE

mesalamine is listed in the FDA National Drug Code directory with 20 NDC codes, marketed under brand names including Pentasa, mesalamine, Lialda. Available dosage forms: capsule, tablet, delayed release, suspension, capsule, extended release.

Drug Details

Generic Name
mesalamine
Brand Names
Pentasa, mesalamine, Lialda, Rowasa, MESALAMINE, sfRowasa Sulfite-Free Formulation, APRISO, Mesalamine
Application Number
NDA020049
Sponsor
Takeda Pharmaceuticals America, Inc.
NDC Codes
20
Dosage Forms
CAPSULE, TABLET, DELAYED RELEASE, SUSPENSION, CAPSULE, EXTENDED RELEASE
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 )