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Tradename: ASACOL

Summary for Tradename: ASACOL

Patents:4
Applicants:1
NDAs:2
Suppliers: see list7
drug
patent expirations by year for
 ASACOL

Pharmacology for Tradename: ASACOL

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: ASACOL

Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
Status: Completed Condition: Healthy

The Colitis Once Daily Asacol Study
Status: Completed Condition: Ulcerative Colitis

Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis
Status: Recruiting Condition: 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

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

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
Status: Terminated Condition: Ulcerative Colitis

Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Status: Completed Condition: Healthy

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

Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Status: Completed Condition: Ulcerative Colitis

Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
Status: Completed Condition: Ulcerative Colitis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651Jan 31, 1992RXYes5,541,170<disabled><disabled>
Warner Chilcott Llc
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651Jan 31, 1992RXYes5,541,171<disabled><disabled>
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830May 29, 2008RXYes5,541,170<disabled>Y<disabled>
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830May 29, 2008RXYes5,541,171<disabled>Y<disabled>
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Paragraph IV activity for: ASACOL

Drugname Dosage Strength RLD Submissiondate
mesalamineDelayed-release Tablets800mgAsacol HD7/13/2011
mesalamineDelayed-release Tablets400 mgAsacol6/22/2007

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