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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212304


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NDA 212304 describes ADLARITY, which is a drug marketed by Corium and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ADLARITY profile page.

The generic ingredient in ADLARITY is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 212304
Tradename:ADLARITY
Applicant:Corium
Ingredient:donepezil hydrochloride
Patents:9
Pharmacology for NDA: 212304
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 212304
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304 NDA Corium, LLC. 65038-055 65038-055-01 1 PATCH in 1 POUCH (65038-055-01)
ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304 NDA Corium, LLC. 65038-055 65038-055-03 4 POUCH in 1 CARTON (65038-055-03) / 1 PATCH in 1 POUCH (65038-055-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYSTEM;TRANSDERMALStrength5MG/DAY
Approval Date:Mar 11, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 11, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jul 26, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Patent:⤷  Sign UpPatent Expiration:Jul 26, 2037Product Flag?YSubstance Flag?Delist Request?

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