Entrectinib
Rozlytrek (entrectinib) is an oral prescription drug by Genentech, Inc., used to treat certain cancers like lung cancer with ROS1 gene changes or solid tumors with NTRK fusions. It comes as 50 mg pellets in dose packs. 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 | Rozlytrek (entrectinib) is an oral prescription drug by Genentech, Inc., used to treat certain cancers like lung cancer with ROS1 gene changes or solid tumors with NTRK fusions. It comes as 50 mg pellets in dose packs. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Entrectinib",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Entrectinib — ANDA 218550 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218550"
}
]
|
| identifier | ANDA218550 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-information",
"drug-manufacturers",
"pharmaceuticals",
"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 | Entrectinib |
