{"@type": "dcat:Dataset", "accessLevel": "public", "accrualPeriodicity": "R/P1Y", "bureauCode": ["009:10"], "contactPoint": {"@type": "vcard:Contact", "fn": "Division of Drug Information", "hasEmail": "mailto:druginfo@fda.hhs.gov"}, "description": "Dutasteride and Tamsulosin Hydrochloride is a prescription capsule combining two medications to treat symptoms of an enlarged prostate (benign prostatic hyperplasia). Dutasteride reduces prostate size by inhibiting hormone production, while tamsulosin relaxes prostate muscles for easier urination. Taken orally, it's available as 0.5 mg dutasteride and 0.4 mg tamsulosin per capsule. This information was generated using AI and is provided for informational and research purposes only.", "distribution": [{"@type": "dcat:Distribution", "description": "\n        Access the FDA dataset for Dutasteride and tamsulosin hydrochloride \u2014 ANDA 213300 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213300", "mediaType": "text/html", "title": "Dutasteride and tamsulosin hydrochloride"}], "identifier": "ANDA213300", "issued": "2016-09-16", "keyword": ["drug-manufacturers", "health-care", "medications", "pharmaceuticals", "public-health"], "landingPage": "https://www.fda.gov/drugs", "license": "https://open.fda.gov/license", "modified": "2025-03-17", "programCode": ["009:002"], "publisher": {"@type": "org:Organization", "name": "U.S. Food and Drug Administration"}, "theme": ["FDA"], "title": "Dutasteride and tamsulosin hydrochloride"}