{"@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": "Duloxetine Hydrochloride is a generic prescription drug that acts as a serotonin and norepinephrine reuptake inhibitor, commonly used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, and chronic pain. It comes in delayed-release capsules with strengths of 20 mg, 30 mg, and 60 mg, taken orally. Manufactured by Aurobindo Pharma Ltd. 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 Duloxetine hydrochloride \u2014 ANDA 090778 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090778", "mediaType": "text/html", "title": "Duloxetine hydrochloride"}], "identifier": "ANDA090778", "issued": "2016-09-16", "keyword": ["drug-manufacturers", "drug-safety", "drug-information", "medications", "pharmaceuticals"], "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": "Duloxetine hydrochloride"}