Enasidenib mesylate
Idhifa (enasidenib mesylate) is a prescription oral tablet that inhibits the IDH2 enzyme, used to treat adults with relapsed or refractory acute myeloid leukemia (AML) who have an IDH2 mutation. Available in 50mg and 100mg strengths. 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 | Idhifa (enasidenib mesylate) is a prescription oral tablet that inhibits the IDH2 enzyme, used to treat adults with relapsed or refractory acute myeloid leukemia (AML) who have an IDH2 mutation. Available in 50mg and 100mg strengths. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Enasidenib mesylate",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Enasidenib mesylate — ANDA 209606 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209606"
}
]
|
| identifier | ANDA209606 |
| issued | 2016-09-16 |
| keyword |
[
"drug-manufacturers",
"drug-safety",
"fda",
"health-care",
"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 | Enasidenib mesylate |
