{"@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": "Procainamide Hydrochloride is a prescription antiarrhythmic medication used to treat certain irregular heart rhythms. It is available as an injectable solution in strengths of 100 mg/mL and 500 mg/mL, administered via intramuscular or intravenous injection. Manufactured by Gland Pharma Limited and others under ANDA218135. 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 Procainamide hydrochloride \u2014 ANDA 206332 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206332", "mediaType": "text/html", "title": "Procainamide hydrochloride"}], "identifier": "ANDA206332", "issued": "2016-09-16", "keyword": ["drug-safety", "drug", "health-care", "pharmaceuticals", "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": "Procainamide hydrochloride"}