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Donidalorsen
Dawnzera (donidalorsen) is a prescription medication by Ionis Pharmaceuticals Inc., administered as a subcutaneous injection in an autoinjector. It contains donidalorsen sodium at 80 mg per 0.8 mL solution, approved for use starting August 21, 2025. 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 | Dawnzera (donidalorsen) is a prescription medication by Ionis Pharmaceuticals Inc., administered as a subcutaneous injection in an autoinjector. It contains donidalorsen sodium at 80 mg per 0.8 mL solution, approved for use starting August 21, 2025. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Donidalorsen",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Donidalorsen — ANDA 219407 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219407"
}
]
|
| identifier | ANDA219407 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-safety",
"fda",
"health-care",
"prescription-drugs"
]
|
| 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 | Donidalorsen |
