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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 019651


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NDA 019651 describes ASACOL, which is a drug marketed by Apil and Abbvie and is included in two NDAs. 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. Forty 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
Medical Subject Heading (MeSH) Categories for 019651

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

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