---
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"
generated_at: "2026-06-20T23:49:16.737032+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Elite Pharmaceuticals files ANDA with FDA for generic dopamine agonist

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-22-036306
- JSON: https://secwatch.observer/filing/0001493152-22-036306.json
- Plain text: https://secwatch.observer/filing/0001493152-22-036306.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.