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Details for Generic Name: mesalamine

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Summary for Generic Name: mesalamine

Drug Master File Entries: see list20
Suppliers: see list15
Therapeutic Class:Inflammatory Bowel Disease Agents

Pharmacology for Ingredient: mesalamine

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: mesalamine

The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Status: Recruiting Condition: Irritable Bowel Syndrome

Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
Status: Completed Condition: Irritable Bowel Syndrome

Cimzia Versus Mesalamine for Crohn's Recurrence
Status: Recruiting Condition: Crohn's Disease

Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
Status: Completed Condition: Ulcerative Colitis

Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine
Status: Completed Condition: Crohn's Disease

Canadian Active & Maintenance Modified Pentasa Study
Status: Completed Condition: Active Ulcerative Colitis; Remission of Ulcerative Colitis

Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)
Status: Completed Condition: Colitis, Ulcerative; Recurrence

Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
Status: Completed Condition: Ulcerative Colitis

Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.
Status: Completed Condition: Ulcerative Colitis

Predicting Response to Standardized Pediatric Colitis Therapy
Status: Recruiting Condition: Ulcerative Colitis

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc
TABLET, DELAYED RELEASE;ORAL019651Jan 31, 1992RXYes5,541,171<disabled><disabled>
Warner Chilcott Llc
TABLET, DELAYED RELEASE;ORAL021830May 29, 2008RXYes6,893,662<disabled>Y<disabled>
TABLET, DELAYED RELEASE;ORAL022000Jan 16, 2007RXYes6,773,720<disabled>Y<disabled>
Meda Pharms
ENEMA;RECTAL019618Jun 20, 2008RXNo7,645,801<disabled>YY<disabled>
Perrigo Israel
ENEMA;RECTAL076751Sep 17, 2004RXNo<disabled><disabled>
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