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Details for New Drug Application (NDA): 022301

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NDA 022301 describes APRISO, which is a drug marketed by Valeant Pharms Intl and is included in one NDA. It is available from two suppliers. There are seven patents 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-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the mesalamine profile page.

Summary for NDA: 022301

Tradename:
APRISO
Applicant:
Valeant Pharms Intl
Ingredient:
mesalamine
Patents:7
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022301

Ingredient-typeAminosalicylic Acids

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 Physicians Total Care, Inc. 54868-6150 54868-6150-0 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54868-6150-0)
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL 022301 NDA Salix Pharmaceuticals, Inc. 65649-103 65649-103-01 1 BOTTLE in 1 CARTON (65649-103-01) > 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Oct 31, 2008TE:RLD:Yes
Patent:8,496,965Patent Expiration:Apr 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:8,940,328Patent Expiration:Apr 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:8,956,647Patent Expiration:Apr 20, 2018Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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