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Generated: November 18, 2018

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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 two 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-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 022000
Tradename:LIALDA
Applicant:Shire
Ingredient:mesalamine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022000
Ingredient-typeAminosalicylic Acids
Medical Subject Heading (MeSH) Categories for 022000
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 AUTHORIZED GENERIC Shire US Manufacturing Inc. 54092-100 54092-100-01 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-100-01)

Profile for product number 001

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

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