Details for New Drug Application (NDA): 215985
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NDA 215985 describes ZORYVE, which is a drug marketed by Arcutis and is included in two NDAs. It is available from one supplier. There are seven 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the roflumilast profile page.
Summary for 215985
| Tradename: | ZORYVE |
| Applicant: | Arcutis |
| Ingredient: | roflumilast |
| Patents: | 6 |
Pharmacology for NDA: 215985
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 215985
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZORYVE | roflumilast | CREAM;TOPICAL | 215985 | NDA | Arcutis Biotherapeutics, Inc. | 80610-130 | 80610-130-60 | 1 TUBE in 1 CARTON (80610-130-60) / 60 g in 1 TUBE |
| ZORYVE | roflumilast | CREAM;TOPICAL | 215985 | NDA | Arcutis Biotherapeutics, Inc. | 80610-130 | 80610-130-96 | 6 TUBE in 1 CARTON (80610-130-96) / 5 g in 1 TUBE (80610-130-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.3% | ||||
| Approval Date: | Jul 29, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 5, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jul 29, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 7, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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