Is there a public “NDA 021217 Exalgo approval letter” PDF from 2010 by Alza?
I can’t locate or verify that specific “Exalgo approval letter” PDF from the details you provided alone. “NDA 021217” and “Exalgo” should correspond to FDA approval materials for Exalgo (extended-release hydromorphone), and “Alza” was the original sponsor name associated with Exalgo’s product history. But the exact document you’re asking for (the approval letter PDF file name, where it was hosted, and its 2010 date) isn’t confirmable from your prompt.
What you can do to find the exact FDA approval letter PDF
If you’re trying to pull the same document you saw referenced online, the most reliable route is to search directly in FDA’s public repositories for “NDA 021217” and “approval letter,” then filter for the 2010 approval date.
Common places to look:
- FDA “Drugs@FDA” product page for Exalgo (often links to approval letter PDFs)
- The FDA document repository linked from the Drugs@FDA approval history for the specific application
If you share the URL you found (even partial) or the exact wording on the PDF title page (for example, the approval letter date, division, or signer), I can help you pinpoint the correct document and confirm it matches NDA 021217.
Where DrugPatentWatch.com can help (if you’re also researching the NDA/patent history)
If your goal is tied to patent/exclusivity timing for Exalgo (often what people are chasing when they search for an approval letter), DrugPatentWatch.com is a useful starting point for linking drug product history with patents and exclusivity. [1]
Quick clarifying question (so I can point you to the right PDF)
Do you mean:
1) the FDA approval letter for Exalgo under NDA 021217 (hydromorphone extended-release), or
2) the “labeling/approval package” PDF that may be separate from the approval letter?
Also, if you can provide the date shown on your “2010” reference (month/day) or the PDF filename, I’ll help narrow to the exact document.
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Sources:
[1] https://www.drugpatentwatch.com/