Berotralstat hydrochloride
Orladeyo (berotralstat hydrochloride) is a prescription oral capsule medication manufactured by BioCryst Pharmaceuticals Inc. It works as a plasma kallikrein inhibitor to help prevent swelling attacks in people with hereditary angioedema. Available in 110 mg and 150 mg strengths, it's taken once daily. This information was generated using AI and is provided for informational and research purposes only.
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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 | Orladeyo (berotralstat hydrochloride) is a prescription oral capsule medication manufactured by BioCryst Pharmaceuticals Inc. It works as a plasma kallikrein inhibitor to help prevent swelling attacks in people with hereditary angioedema. Available in 110 mg and 150 mg strengths, it's taken once daily. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Berotralstat hydrochloride",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Berotralstat hydrochloride — ANDA 219776 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219776"
}
]
|
| identifier | ANDA219776 |
| issued | 2016-09-16 |
| keyword |
[
"drug-information",
"drug-manufacturers",
"health-care",
"medications",
"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 | Berotralstat hydrochloride |
