What does an “LIVTENCITY approval letter” NDA 215596 mean?
An “FDA approval letter” for LIVTENCITY is the official FDA document that approves the marketing application (an NDA or supplement) for that product. “NDA 215596” is the specific New Drug Application number in the FDA drug-approval system that ties to that approval letter. The FDA uses these identifiers to link the application, review, and decision documents.
Where can you find the exact FDA approval letter for NDA 215596?
The FDA typically publishes approval letters and related review documents in public databases tied to the NDA number (for example, the Drugs@FDA record for the NDA). To find the exact approval letter, use the NDA number “215596” in the FDA’s Drugs@FDA search (or the associated application document links from that page).
Who is the “Regulatory Project Manager” on the approval letter?
The “Regulatory Project Manager” is the specific FDA staff member named on the approval letter, responsible for coordinating the review and action on that application. The only authoritative way to know the exact person’s name for LIVTENCITY under NDA 215596 is to read the approval letter itself (the letter’s header/signature block typically lists the FDA contacts and office information).
If you paste the text of the approval letter (or the signature/contact section), I can extract the Regulatory Project Manager name and related FDA office details from it.
How can you verify you’re looking at the right approval letter?
For NDA-linked approval letters, common sources of confusion are:
- The application is an NDA, but the product might also have different supplement approvals (different approval letters).
- The approval letter may be for the original NDA vs. a later efficacy/safety supplement.
Using “NDA 215596” as the key and confirming the product name and approval date in the approval letter reduces the chance of grabbing the wrong document.
What to do if you can’t find the approval letter in public sources
If you have the NDA number (215596) but no longer see the letter online, options include:
- Checking the Drugs@FDA record for archived document links.
- Using the FDA document search tied to the application number.
- Consulting the FDA’s publicly posted review/document bundles if they include the approval letter.
If you tell me whether you’re searching by website, PDF, or an internal document portal, I can suggest the most direct path for that scenario.
Quick next step
If you share either:
1) the URL to the approval letter page/PDF, or
2) the approval letter text (especially the signature/contact block),
I’ll pull out the exact “Regulatory Project Manager” name tied to LIVTENCITY for NDA 215596.