{"@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": "Femynor is a discontinued oral contraceptive pill containing norgestimate (0.25 mg) and ethinyl estradiol (0.035 mg), used to prevent pregnancy by regulating hormones. Manufactured by Amneal Pharmaceuticals NY LLC under ANDA203865. 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 Norgestimate and ethinyl estradiol \u2014 ANDA 090793 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090793", "mediaType": "text/html", "title": "Norgestimate and ethinyl estradiol"}], "identifier": "ANDA090793", "issued": "2016-09-16", "keyword": ["drug", "drug-information", "drug-manufacturers", "drug-safety", "prescription-drugs"], "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": "Norgestimate and ethinyl estradiol"}