Details for New Drug Application (NDA): 212304
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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 Action | Cholinesterase 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: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 5MG/DAY | ||||
Approval Date: | Mar 11, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Mar 11, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 26, 2037 | Product 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 Up | Patent Expiration: | Jul 26, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? |
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