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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 022301


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NDA 022301 describes APRISO, which is a drug marketed by Salix and is included in one NDA. It is available from six suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the APRISO profile page.

The generic ingredient in APRISO is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 022301
Tradename:APRISO
Applicant:Salix
Ingredient:mesalamine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022301
Medical Subject Heading (MeSH) Categories for 022301
Suppliers and Packaging for NDA: 022301
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-9224 0093-9224-89 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89)
APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-884 43353-884-79 2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-884-79)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Oct 31, 2008TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:May 1, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS

Expired US Patents for NDA 022301

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
Salix APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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