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Last Updated: October 20, 2021

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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. 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. Thirty-one 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019651
Paragraph IV (Patent) Challenges for 019651
Tradename Dosage Ingredient NDA Submissiondate
ASACOL TABLET, DELAYED RELEASE;ORAL mesalamine 019651 2007-06-22

Profile for product number 001

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

Expired US Patents for NDA 019651

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 ⤷  Free Forever Trial ⤷  Free Forever Trial
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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