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Details for New Drug Application (NDA): 202811

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NDA 202811 describes LINZESS, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from three suppliers. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LINZESS profile page.

The generic ingredient in LINZESS is linaclotide. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linaclotide profile page.

Summary for NDA: 202811

Tradename:
LINZESS
Applicant:
Forest Labs Llc
Ingredient:
linaclotide
Patents:9
Formulation / Manufacturing:see details

Pharmacology for NDA: 202811

Mechanism of ActionGuanylate Cyclase Activators

Suppliers and Packaging for NDA: 202811

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LINZESS
linaclotide
CAPSULE;ORAL 202811 NDA ALLERGAN, INC. 0456-1201 0456-1201-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0456-1201-30)
LINZESS
linaclotide
CAPSULE;ORAL 202811 NDA ALLERGAN, INC. 0456-1202 0456-1202-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0456-1202-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength145MCG
Approval Date:Aug 30, 2012TE:RLD:No
Patent:7,371,727Patent Expiration:Jan 28, 2024Product Flag?Substance Flag?YDelist Request?
Patent:7,704,947Patent Expiration:Jan 28, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:7,745,409Patent Expiration:Jan 28, 2024Product Flag?YSubstance Flag?YDelist Request?


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