mesalamine

FDA Drug Profile — mesalamine, MESALAMINE, Rowasa, Mesalamine, APRISO

Drug Details

Generic Name
mesalamine
Brand Names
mesalamine, MESALAMINE, Rowasa, Mesalamine, APRISO, Pentasa, Lialda, sfRowasa Sulfite-Free Formulation
Application Number
ANDA091640
Sponsor
Cosmo SpA
NDC Codes
19
Dosage Forms
TABLET, DELAYED RELEASE, SUSPENSION, CAPSULE, EXTENDED RELEASE, CAPSULE
Routes
ORAL, RECTAL
Active Ingredients
MESALAMINE

Indications and Usage

1 INDICATIONS AND USAGE Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. Mesalamine extended-release capsules are an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults. (1)