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. Forty-one suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
The generic ingredient in ADLARITY is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Forty-one 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 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | Jul 26, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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