{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-23-033590","form_type":"8-K","ticker":"ELTP","cik":"0001053369","company_name":"ELITE PHARMACEUTICALS INC /NV/","filed_at":"2023-09-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.029055+00:00","generated_at":"2026-06-10T09:07:17.654585+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Elite Pharmaceuticals files ANDA for generic opiate analgesic with $720M market","bullets":["Filed ANDA with FDA on August 17, 2023 for a generic opiate analgesic product.","FDA accepted the ANDA for review on September 19, 2023.","IQVIA reported $720 million in annual brand and generic sales for this product (12 months ending June 2023).","The specific drug product remains undisclosed."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-23-033590","json":"https://secwatch.observer/filing/0001493152-23-033590.json","markdown":"https://secwatch.observer/filing/0001493152-23-033590.md","text":"https://secwatch.observer/filing/0001493152-23-033590.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1053369/000149315223033590/0001493152-23-033590-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1053369/000149315223033590/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T09:07:17.654585+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}