secwatch.observer — SEC 8-K summary
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Issuer:     ELITE PHARMACEUTICALS INC /NV/ (ELTP)
CIK:        0001053369
Form:       8-K
Filed at:   2022-12-22T23:59:59+00:00
Accession:  0001493152-22-036306
Event type: regulatory
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Elite Pharmaceuticals files ANDA with FDA for generic dopamine agonist
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1053369/000149315222036306/0001493152-22-036306-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1053369/000149315222036306/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-22-036306

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer