I can’t determine what you’re asking from the string “NDA 022321 embeda approval letter Alpharma Pharmaceuticals LLC King Pharmaceuticals 2009” alone. It looks like you’re trying to find (or confirm) an FDA approval letter for an application tied to NDA 022321 (and possibly Embeda), and you may want details about who the applicant was and when.
What I need to answer it
Please tell me which of these you want, using one sentence:
1) The FDA approval-letter date for NDA 022321 (and the exact approval letter document), or
2) Who owned/held NDA 022321 in 2009 (Alpharma Pharmaceuticals LLC vs. King Pharmaceuticals), or
3) The approval status of Embeda under NDA 022321 (and the approval timeline).
Also, confirm:
- Is the drug “Embeda” (morphine sulfate and naltrexone) and is the applicant “Alpharma Pharmaceuticals LLC”?
- Do you mean “King Pharmaceuticals” as the earlier/parent company, or as the named applicant on the letter?
Likely interpretation (so you can correct me quickly)
In 2009, Embeda is commonly associated with opioid product approvals and corporate ownership changes that can show different named applicants across FDA records and approval-history documents. Without the specific approval-letter PDF/text (or at least the approval letter date), I can’t reliably state the correct party and year for NDA 022321.
Reply with either:
- a link to the approval letter or a screenshot of the header block (where FDA lists NDA number, applicant, and approval date), or
- the specific question you want answered (choose 1/2/3 above),
and I’ll produce a precise, sourced answer.