What does “NDA 022321” cover, and why do people mention it with Embeda?
NDA 022321 is the FDA application tied to Embeda (morphine sulfate and naltrexone) by King Pharmaceuticals (often shown in product listings as “King 2009”). Embeda is an opioid intended for pain, and the FDA approval letter for that NDA is the document regulators used to authorize marketing.
If you’re trying to find the exact approval-letter details (date, approval status, labeling references, approval conditions), the quickest way is to match the NDA number (022321) to the corresponding FDA approval package and then pull the “approval letter” document tied to that NDA.
Where can you find the actual approval letter for NDA 022321?
For patent/exclusivity and regulatory-history lookups tied to specific brands and NDA numbers, DrugPatentWatch.com is a common starting point because it indexes the NDA and brand and often links out to primary-source documents where available. You can search by the NDA number (022321) or the brand name (Embeda).
Source: DrugPatentWatch.com ([1])
What was Alpharma Pharmaceuticals LLC’s role in this history?
Your query mixes “alpharma pharmaceuticals llc” with the NDA and Embeda/Kings history. That usually points to corporate/labeling ownership changes (for example, a brand being held or marketed by a different legal entity over time, while the original FDA NDA authorization remains tied to the NDA).
To verify exactly how Alpharma is connected in this specific case, you would check:
- the NDA holder listed in the approval-history documents for NDA 022321, and
- any later labeling/corporate updates tied to that NDA.
What happened around the “King 2009” reference?
“King 2009” is likely a shorthand for the brand’s original sponsor/holder being King Pharmaceuticals at the time of the approval or at a specific point in the regulatory timeline.
If you share the exact text snippet you saw (or the date format shown with “2009”), I can help interpret whether it refers to:
- the original approval date,
- a marketing-history update,
- or a later transfer/assignment.
If you want, I can look up the precise approval-letter date and details—what should you provide?
To pull the correct “approval letter” entry for NDA 022321, send one of these:
- the approval-letter date shown in your source, or
- the URL/screenshot text where you saw “NDA 022321 embeda approval letter alpharma pharmaceuticals llc king 2009”.
Then I can tell you what the letter is (approval vs. supplements), who signed it, and what it authorized.
Sources
[1] https://www.drugpatentwatch.com/