ZORYVE DIN 02570793
Health Canada record
| Active ingredient(s) | ROFLUMILAST 0.05 % |
|---|---|
| Dosage form | Cream |
| Route | Topical |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | D05AX06 ROFLUMILAST |
| Original market date | 20-Aug-2026 |
| Current status date | 20-Aug-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Arcutis Canada, Inc. — licence 3-002825, currently licensed, last inspection rating C (2023-08-22).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ROFLUMILAST
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02359456 | DAXAS | ASTRAZENECA CANADA INC | Tablet | ROFLUMILAST 500 MCG | Marketed |
| 02537532 | ZORYVE | ARCUTIS CANADA, INC. | Cream | ROFLUMILAST 0.3 % | Marketed |
| 02552566 | ZORYVE | ARCUTIS CANADA, INC. | Foam | ROFLUMILAST 0.3 % | Marketed |
| 02556146 | ZORYVE | ARCUTIS CANADA, INC. | Cream | ROFLUMILAST 0.15 % | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 38144 | 2026-08-19 | Supplement to a New Drug Submission (SNDS) | Addition of new pediatric indication: ZORYVE® (roflumilast cream, 0.05%) is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. Addition of new strength: 0.05% w/w cream |
International API supply for ROFLUMILAST
13 active FDA Drug Master Files.
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