Sapropterin dihydrochloride
KUVAN (sapropterin dihydrochloride) is an oral prescription powder used to lower phenylalanine levels in people with phenylketonuria (PKU) who respond to it. Available in 100 mg and 500 mg packets, it's manufactured by BioMarin Pharmaceutical Inc. 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 | KUVAN (sapropterin dihydrochloride) is an oral prescription powder used to lower phenylalanine levels in people with phenylketonuria (PKU) who respond to it. Available in 100 mg and 500 mg packets, it's manufactured by BioMarin Pharmaceutical Inc. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Sapropterin dihydrochloride",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Sapropterin dihydrochloride — ANDA 210027 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210027"
}
]
|
| identifier | ANDA210027 |
| issued | 2016-09-16 |
| keyword |
[
"drug-information",
"drug-manufacturers",
"fda",
"prescription-drugs",
"public-health"
]
|
| 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 | Sapropterin dihydrochloride |
