{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-22-036306","form_type":"8-K","ticker":"ELTP","cik":"0001053369","company_name":"ELITE PHARMACEUTICALS INC /NV/","filed_at":"2022-12-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:49.432268+00:00","generated_at":"2026-06-20T23:49:16.737032+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"Elite Pharmaceuticals files ANDA with FDA for generic dopamine agonist","bullets":["Filed Abbreviated New Drug Application (ANDA) with FDA for an undisclosed extended-release dopamine agonist generic.","Reference product had total US sales of ~$12 million for 12 months ending August 31, 2022, per IQVIA.","Specific drug and formulation are not disclosed in the press release.","ANDA submission is a step toward marketing approval for a niche generic product."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-22-036306","json":"https://secwatch.observer/filing/0001493152-22-036306.json","markdown":"https://secwatch.observer/filing/0001493152-22-036306.md","text":"https://secwatch.observer/filing/0001493152-22-036306.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1053369/000149315222036306/0001493152-22-036306-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1053369/000149315222036306/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-20T23:49:16.737032+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"}