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-three 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

Anti-Inflammatory Agents, Non-Steroidal

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	1.2GM
Approval Date:	Jan 16, 2007	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 26, 2023
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 022000

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	LIALDA	mesalamine	TABLET, DELAYED RELEASE;ORAL	022000-001	Jan 16, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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