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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019651

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NDA 019651 describes ASACOL, which is a drug marketed by Apil and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ASACOL profile page.

The generic ingredient in ASACOL is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 019651
Tradename:ASACOL
Applicant:Apil
Ingredient:mesalamine
Patents:0
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 019651
Ingredient-typeAminosalicylic Acids
Medical Subject Heading (MeSH) Categories for 019651
Suppliers and Packaging for NDA: 019651
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651 NDA Allergan, Inc. 0023-0752 N 0023-0752-27
ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651 NDA KAISER FOUNDATION HOSPITALS 0179-0111 N 0179-0111-70

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength400MG
Approval Date:Jan 31, 1992TE:RLD:No

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