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 nineteen 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. Sixteen 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. Sixteen 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: | 19 |
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 | ||||||||
| Regulatory Exclusivity Expiration: | May 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PLAQUE PSORIASIS OF THE SCALP AND BODY IN PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 10,940,142 | Patent Expiration: | Jun 7, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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