{"@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": "Estradiol and Norethindrone Acetate is a prescription oral tablet combining estrogen (estradiol) and progestin (norethindrone acetate) to help manage menopause symptoms like hot flashes and prevent bone loss. Each tablet contains 1 mg estradiol and 0.5 mg norethindrone acetate, manufactured by Naari Pte. Limited as a generic version. 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 Estradiol and norethindrone acetate \u2014 ANDA 079193 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=079193", "mediaType": "text/html", "title": "Estradiol and norethindrone acetate"}], "identifier": "ANDA079193", "issued": "2016-09-16", "keyword": ["drug-manufacturers", "drug-safety", "health-care", "medications", "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": "Estradiol and norethindrone acetate"}