Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215985

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ZORYVE (ROFLUMILAST)
0.15%
Marketing Status: Prescription

Active Ingredient: ROFLUMILAST
Proprietary Name: ZORYVE
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.15%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215985
Product Number: 002
Approval Date: Jul 9, 2024
Applicant Holder Full Name: ARCUTIS BIOTHERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZORYVE (ROFLUMILAST)
0.3%
Marketing Status: Prescription

Active Ingredient: ROFLUMILAST
Proprietary Name: ZORYVE
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215985
Product Number: 001
Approval Date: Jul 29, 2022
Applicant Holder Full Name: ARCUTIS BIOTHERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZORYVE (ROFLUMILAST)
0.05%
Marketing Status: Prescription

Active Ingredient: ROFLUMILAST
Proprietary Name: ZORYVE
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 0.05%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215985
Product Number: 003
Approval Date: Oct 4, 2025
Applicant Holder Full Name: ARCUTIS BIOTHERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information