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Last Updated: October 27, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022000


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NDA 022000 describes LIALDA, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. 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. Thirty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 022000
Tradename:LIALDA
Applicant:Takeda Pharms Usa
Ingredient:mesalamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022000
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 AUTHORIZED GENERIC Takeda Pharmaceuticals America, Inc. 54092-100 54092-100-01 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-100-01)
LIALDA mesalamine TABLET, DELAYED RELEASE;ORAL 022000 NDA Takeda Pharmaceuticals America, Inc. 54092-476 54092-476-01 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
Paragraph IV (Patent) Challenges for 022000
Tradename Dosage Ingredient NDA Submissiondate
LIALDA TABLET, DELAYED RELEASE;ORAL mesalamine 022000 2009-12-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength1.2GM
Approval Date:Jan 16, 2007TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jun 26, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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