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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Citi
Cantor Fitzgerald
Mallinckrodt
Julphar
Fuji
Dow
Cerilliant
Argus Health

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020049

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NDA 020049 describes PENTASA, which is a drug marketed by Shire and is included in one NDA. It is available from five suppliers. Additional details are available on the PENTASA profile page.

The generic ingredient in PENTASA is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 020049
Tradename:PENTASA
Applicant:Shire
Ingredient:mesalamine
Patents:0
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020049
Ingredient-typeAminosalicylic Acids
Medical Subject Heading (MeSH) Categories for 020049
Suppliers and Packaging for NDA: 020049
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049 NDA Shire US Manufacturing Inc. 54092-189 N 54092-189-81
PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049 NDA Shire US Manufacturing Inc. 54092-191 N 54092-191-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength250MG
Approval Date:May 10, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jul 8, 2004TE:RLD:Yes

Expired US Patents for NDA 020049

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Cipla
Covington
Merck
Citi
Boehringer Ingelheim
Moodys
Argus Health

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