Fedratinib hydrochloride
Inrebic is a prescription oral capsule containing 100 mg of fedratinib hydrochloride, used for certain blood disorders. Manufactured by Celgene Corporation under NDA212327, it was approved in August 2019. 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 | Inrebic is a prescription oral capsule containing 100 mg of fedratinib hydrochloride, used for certain blood disorders. Manufactured by Celgene Corporation under NDA212327, it was approved in August 2019. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[ { "@type": "dcat:Distribution", "title": "Fedratinib hydrochloride", "mediaType": "text/html", "description": " Access the FDA dataset for Fedratinib hydrochloride — ANDA 212327 submitted by Mylan Institutional LLC ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212327" } ] |
| identifier | ANDA212327 |
| issued | 2016-09-16 |
| keyword |
[ "drug-manufacturers", "drug-safety", "fda", "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 | Fedratinib hydrochloride |
