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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021830

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NDA 021830 describes ASACOL HD, which is a drug marketed by Apil and is included in one NDA. It is available from four suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ASACOL HD profile page.

The generic ingredient in ASACOL HD is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 021830
Tradename:ASACOL HD
Applicant:Apil
Ingredient:mesalamine
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021830
Medical Subject Heading (MeSH) Categories for 021830
Suppliers and Packaging for NDA: 021830
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830 NDA Allergan, Inc. 0023-5901 0023-5901-18 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0023-5901-18)
ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-3497 50090-3497-0 180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3497-0)
Paragraph IV (Patent) Challenges for 021830
Tradename Dosage Ingredient NDA Submissiondate
ASACOL HD TABLET, DELAYED RELEASE;ORAL mesalamine 021830 2011-07-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength800MG
Approval Date:May 29, 2008TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ULCERATIVE COLITIS
Patent:  Start TrialPatent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?

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