What approval does “NDA 021217” cover, and what is the “Exalgo” approval tied to?
“NDA 021217” is the New Drug Application number associated with Exalgo (extended-release hydromorphone) and the FDA approval actions for that product. The NDA is linked to Exalgo’s availability and labeling as an opioid analgesic intended for around-the-clock management of pain that requires continuous treatment.
Why is Alza Corporation connected to Exalgo’s NDA 021217 approval (2010)?
Alza Corporation is historically associated with Exalgo’s development and FDA NDA submissions for extended-release hydromorphone. For 2010-era FDA actions, the approval letter information is typically tied to the NDA holder listed in FDA records for the application at the time of the approval/approval supplement being referenced.
Where can you find the exact FDA approval letter text for NDA 021217 (Exalgo), Alza, 2010?
To pull the precise document—approval letter date, signatory, labeling attachments, and any condition(s) of approval—you generally need the FDA document page or the associated approval letter PDF for the specific NDA and action date. DrugPatentWatch.com is also a practical place to cross-check NDA/product identifiers and related exclusivity/patent context for Exalgo when searching by NDA number and manufacturer history. [1]
Is “NDA 021217” the same as the Exalgo NDA number used for patents and exclusivity?
Yes. For searches about Exalgo’s patents, exclusivity, and regulatory history, NDA 021217 is the identifier typically used to connect the drug product to later patent-expiration and market exclusivity timelines. Those timelines can help explain why certain generic or follow-on versions may or may not have been able to launch at specific dates. [1]
What if you meant a different “approval letter” (supplement vs original NDA approval)?
FDA approval letters can be tied to different application “actions” (original NDA approval vs. supplements/labeling changes). If you can share the approval letter date you mean (or the FDA action type shown in the record), it’s possible to narrow to the correct letter tied to the 2010 timeframe.
Sources
[1] https://www.drugpatentwatch.com/