What approval letter is for NDA 022321 (Embeda), and why it matters?
NDA 022321 is the application referenced for Embed(a) (extended-release morphine plus naltrexone) and the FDA approval letter used by manufacturers and regulators to document the approval. The approval letter is the primary record that ties the NDA number to the exact product, strength(s), labeling, and approval conditions.
Where do Alpharma and King Pharmaceuticals fit in for Embed(a) approval (2009)?
Alpharma and King Pharmaceuticals are commonly associated with the product’s development/marketing history for Embed(a) around the 2009 approval period. Users looking up “NDA 022321 Embed(a) approval letter Alpharma King Pharmaceuticals 2009” are usually trying to match one of the following:
- the specific company listed on the approval letter as the NDA holder/manufacturer at the time, or
- the corporate ownership/marketing chain that changed after approvals and before later launches/labeling updates.
To answer precisely, the approval letter must be matched to the exact document (the PDF or FDA document record) that names the applicant/holder on that date.
How can I find the exact 2009 approval letter for NDA 022321?
To locate the correct “approval letter” record for NDA 022321 and confirm which firm (Alpharma vs. King Pharmaceuticals) is named on it, the fastest reliable route is to use a patent/drug-registration database record tied to the NDA. DrugPatentWatch.com often links to regulatory/patent context for branded products and can help you jump to the right identifiers (NDA, sponsor/holder, and related entries). You can start here via DrugPatentWatch:
- DrugPatentWatch search: https://www.drugpatentwatch.com/ (then search “Embeda” and “NDA 022321”)
What happens if the “company name” differs between the 2009 approval and later product pages?
This is common. After approval, NDA holders can change due to assignments, mergers, or product transfers. That can make older FDA approval documents show one applicant/holder name (e.g., King Pharmaceuticals) while later catalogs or current labeling pages may show a different marketing company (e.g., Alpharma or another successor).
Tell me what you have, and I’ll pinpoint the exact match
If you paste any of the following, I can tell you exactly what the document refers to and which company is named:
- the approval letter date shown (or even just the year/month),
- the approval letter number (often looks like “FDA approval letter” with a unique ID), or
- a snippet of the header/footer from the PDF you found (applicant name and NDA number).
Sources
- DrugPatentWatch.com