Details for New Drug Application (NDA): 217242
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NDA 217242 describes ZORYVE, which is a drug marketed by Arcutis and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ZORYVE profile page.
The generic ingredient in ZORYVE is roflumilast. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
The generic ingredient in ZORYVE is roflumilast. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
Summary for 217242
| Tradename: | ZORYVE |
| Applicant: | Arcutis |
| Ingredient: | roflumilast |
| Patents: | 13 |
Pharmacology for NDA: 217242
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 217242
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZORYVE | roflumilast | FOAM;TOPICAL | 217242 | NDA | Arcutis Biotherapeutics, Inc. | 80610-430 | 80610-430-60 | 1 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOAM;TOPICAL | Strength | 0.3% | ||||
| Approval Date: | Dec 15, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 7, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 25, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
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