Pirfenidone
Pirfenidone is a prescription oral tablet medication used to treat idiopathic pulmonary fibrosis. Available in strengths of 267 mg, 534 mg, and 801 mg, it belongs to the pyridone class of drugs. Manufactured by ANI Pharmaceuticals, Inc. and Laurus Labs Limited under ANDA212722. 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 | Pirfenidone is a prescription oral tablet medication used to treat idiopathic pulmonary fibrosis. Available in strengths of 267 mg, 534 mg, and 801 mg, it belongs to the pyridone class of drugs. Manufactured by ANI Pharmaceuticals, Inc. and Laurus Labs Limited under ANDA212722. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Pirfenidone",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Pirfenidone — ANDA 212759 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212759"
}
]
|
| identifier | ANDA212759 |
| issued | 2016-09-16 |
| keyword |
[
"drug-information",
"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 | Pirfenidone |
