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Profile for Tradename: ASACOL HD

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Asacol Hd is a drug marketed by Warner Chilcott Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ASACOL HD is mesalamine. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for Tradename: ASACOL HD

Patents:3
Applicants:1
NDAs:1
Suppliers: see list1

Pharmacology for Tradename: ASACOL HD

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: ASACOL HD

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 HD
mesalamine
TABLET, DELAYED RELEASE; ORAL021830May 29, 2008RXYes5,541,171<disabled>Y<disabled>
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE; ORAL021830May 29, 2008RXYes<disabled><disabled>
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE; ORAL021830May 29, 2008RXYes6,893,662<disabled>Y<disabled>
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE; ORAL021830May 29, 2008RXYes5,541,170<disabled>Y<disabled>
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Paragraph IV activity for: ASACOL HD

Drugname Dosage Strength RLD Submissiondate
mesalamineDelayed-release Tablets800 mgAsacol HD7/13/2011
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