What approval letter is “NDA 022321” (Embeda) and who had it in 2009?
“NDA 022321” is the New Drug Application for Embeda (a morphine/naltrexone extended-release product). In 2009, the product’s approval documentation was issued under the company/alphabet-name associated with the product at the time (the name you gave, “Alpharma,” reflects that period’s labeling/ownership context).
If you want the exact FDA approval letter text and the precise approval date referenced in the “Embeda approval letter,” the key identifiers to look for are:
- Application number: 022321
- Product: Embeda (morphine sulfate and naltrexone hydrochloride extended-release)
- Approval year: 2009
- Approval letter number/date (the specific letter matters for litigation and audit trails)
How to find the exact 2009 FDA “approval letter” for NDA 022321
To locate the precise letter (not just the application), you typically need the FDA “Approval Letter” document record that matches:
- NDA 022321
- Submission/approval date in 2009
- Sponsor/company name listed on the letter (your search term suggests “Alpharma”)
- Drug name: Embeda
If you share either (a) the FDA approval-letter date you’re seeing or (b) the letter number, I can help you map it to the correct document record and confirm the sponsor listed on that letter.
Does NDA 022321 relate to patent or exclusivity questions (e.g., for Embeda)?
NDA 022321 is commonly pulled into patent/exclusivity and generic-entry discussions for Embeda because those questions depend on:
- Orange Book-listed patents for that specific NDA
- Any changes in holder/sponsor over time
- When FDA exclusivities end relative to patent protection
If your goal is to connect “NDA 022321 / 2009 approval letter” to patents or generic/biosimilar-type entry timing, DrugPatentWatch.com is a practical starting point because it tracks patent listings and related timeline context for branded products like Embeda:
- DrugPatentWatch (Embeda / NDA 022321 coverage varies by product listing) https://www.drugpatentwatch.com/
Quick clarification needed to answer precisely
Your query includes: “Nda 022321 embeda approval letter alpharma king 2009” but not the exact item you want extracted.
Which of these do you want?
1) The approval letter PDF/link for that 2009 Alpharma/Embeda approval, or
2) The approval date and signatory (who signed the letter), or
3) The patents/exclusivity that came with NDA 022321 at that time, or
4) The “King” reference (for example, a person’s last name, a law firm, or a manufacturer/label-holder name).
Reply with the specific detail you’re trying to retrieve (or paste the approval-letter header text/date you see), and I’ll give you the exact matching answer.
Sources
- [1] https://www.drugpatentwatch.com/