Details for New Drug Application (NDA): 215985
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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 215985
Tradename: | ZORYVE |
Applicant: | Arcutis |
Ingredient: | roflumilast |
Patents: | 12 |
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. | 80610-115 | 80610-115-60 | 1 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE |
ZORYVE | roflumilast | CREAM;TOPICAL | 215985 | NDA | Arcutis Biotherapeutics, Inc. | 80610-115 | 80610-115-96 | 6 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05) |
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: | ⤷ Sign Up | Patent Expiration: | Jun 7, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? |
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