File New Drug Application for ET-600 with FDA
Delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 7 Feb 2025
- Due
- 30 Jun 2025
- Delivered
- 28 Apr 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“the company anticipates filing a New Drug Application (NDA) with the FDA for the product by the second quarter of 2025”
What we found
Evidence strength A What the grades mean
Eton Pharmaceuticals submitted the NDA for ET-600 to the FDA on April 28, 2025, within the stated Q2 2025 deadline.
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A Eton Pharmaceuticals Announces Submission of NDA for ET-600 (Desmopressin Oral Solution) 8-K press release confirming NDA submission to FDA on April 28, 2025
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A Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 8-K confirming FDA accepted the NDA and assigned Feb 25, 2026 PDUFA date
Checked 16 Sep 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory submission
- Indicative materiality
- High rules
- Action
- File
- Language
- Expected (“expects”, “plans”)
How this entry was checked
- Commitment recordedRecorded from the company's filing.
- First checkAn AI model read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Gemini (Google), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2025-ETON-000393 · Corrections policy