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Serving 500+ biopharmaceutical companies globally:

Novartis
Accenture
McKesson
Cantor Fitzgerald
Federal Trade Commission
Argus Health
Julphar
Deloitte
US Army
Daiichi Sankyo

Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022000

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NDA 022000 describes LIALDA, which is a drug marketed by Shire and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the LIALDA profile page.

The generic ingredient in LIALDA is mesalamine. There are twenty-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for NDA: 022000

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022000

Ingredient-typeAminosalicylic Acids

Suppliers and Packaging for NDA: 022000

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIALDA
mesalamine
TABLET, DELAYED RELEASE;ORAL 022000 NDA KAISER FOUNDATION HOSPITALS 0179-0142 0179-0142-70 30 TABLET, DELAYED RELEASE in 1 BOX, UNIT-DOSE (0179-0142-70)
LIALDA
mesalamine
TABLET, DELAYED RELEASE;ORAL 022000 NDA Shire US Manufacturing Inc. 54092-476 54092-476-01 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength1.2GM
Approval Date:Jan 16, 2007TE:ABRLD:Yes
Patent:6,773,720Patent Expiration:Jun 8, 2020Product Flag?YSubstance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
AstraZeneca
Daiichi Sankyo
Express Scripts
Harvard Business School
Citi
Accenture
Johnson and Johnson
Baxter

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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