mesalamine

FDA Drug Profile — Lialda, mesalamine, sfRowasa Sulfite-Free Formulation, MESALAMINE, Pentasa

Drug Details

Generic Name
mesalamine
Brand Names
Lialda, mesalamine, sfRowasa Sulfite-Free Formulation, MESALAMINE, Pentasa, Rowasa, Mesalamine, APRISO
Application Number
NDA022000
Sponsor
Takeda Pharmaceuticals America, Inc.
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 )