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Dutasteride
Dutasteride is a prescription oral capsule (0.5 mg) that acts as a 5-alpha reductase inhibitor, commonly used to treat benign prostatic hyperplasia (enlarged prostate) and male pattern hair loss. Manufactured by Amneal Pharmaceuticals LLC under ANDA203118. 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 | Dutasteride is a prescription oral capsule (0.5 mg) that acts as a 5-alpha reductase inhibitor, commonly used to treat benign prostatic hyperplasia (enlarged prostate) and male pattern hair loss. Manufactured by Amneal Pharmaceuticals LLC under ANDA203118. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Dutasteride",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Dutasteride — ANDA 204376 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204376"
}
]
|
| identifier | ANDA204376 |
| issued | 2016-09-16 |
| keyword |
[
"drug-information",
"drug-safety",
"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 | Dutasteride |
