Isotretinoin
Isotretinoin is a prescription retinoid medication available as oral capsules in strengths of 10mg, 20mg, 30mg, and 40mg. Manufactured by Zydus Pharmaceuticals USA Inc. and Zydus Lifesciences Limited, it's used for treating certain skin conditions like severe acne. This generic drug (ANDA211568) was approved for marketing starting September 2023. 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 | Isotretinoin is a prescription retinoid medication available as oral capsules in strengths of 10mg, 20mg, 30mg, and 40mg. Manufactured by Zydus Pharmaceuticals USA Inc. and Zydus Lifesciences Limited, it's used for treating certain skin conditions like severe acne. This generic drug (ANDA211568) was approved for marketing starting September 2023. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Isotretinoin",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Isotretinoin — ANDA 213571 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213571"
}
]
|
| identifier | ANDA213571 |
| issued | 2016-09-16 |
| keyword |
[
"drug-manufacturers",
"drug-safety",
"medications",
"pharmaceuticals",
"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 | Isotretinoin |
