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Roflumilast
ZORYVE is a prescription topical foam containing roflumilast (0.3%), a phosphodiesterase 4 inhibitor used to treat plaque psoriasis in adults. It reduces inflammation in the skin. Manufactured by Arcutis Biotherapeutics, Inc., and approved under NDA217242, it was launched in December 2023. This information was generated using AI and is provided for informational and research purposes only.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1Y |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "Division of Drug Information",
"@type": "vcard:Contact",
"hasEmail": "mailto:druginfo@fda.hhs.gov"
}
|
| description | ZORYVE is a prescription topical foam containing roflumilast (0.3%), a phosphodiesterase 4 inhibitor used to treat plaque psoriasis in adults. It reduces inflammation in the skin. Manufactured by Arcutis Biotherapeutics, Inc., and approved under NDA217242, it was launched in December 2023. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Roflumilast",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Roflumilast — ANDA 208213 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208213"
}
]
|
| identifier | ANDA208213 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-information",
"fda",
"health-care",
"pharmaceuticals"
]
|
| landingPage | https://www.fda.gov/drugs |
| license | https://open.fda.gov/license |
| modified | 2025-03-17 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Roflumilast |
