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 five 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-eight 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

Pharmacology for NDA: 022301

Medical Subject Heading (MeSH) Categories for 022301

Anti-Inflammatory Agents, Non-Steroidal

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:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	375MG
Approval Date:	Oct 31, 2008	TE:	AB	RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	May 1, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS

Expired US Patents for NDA 022301

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

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