What does “FDA tranylcypromine NDA” mean?
Tranylcypromine is an older antidepressant (a monoamine oxidase inhibitor). An “NDA” (New Drug Application) is the FDA marketing application a company files for approval of a drug. For an older product like tranylcypromine, the key practical question is often not “what NDA was filed,” but “what FDA product/approval records apply to tranylcypromine” and whether there are current applications, supplements, or label revisions for the marketed product.
Is tranylcypromine currently approved through an NDA?
Tranylcypromine is FDA-approved and marketed (historically under older NDA pathways). To answer the exact “NDA number” and the current marketing authorization details (applicant/holder, approval date, current label), you typically need the specific product entry in the FDA’s drug-application databases (Drug NDC Directory / Drugs@FDA). The user-provided prompt doesn’t include the product manufacturer (NDC/label name), so multiple marketed versions could exist with different labeling history.
How do I find the exact NDA for the specific tranylcypromine product?
The fastest way is to identify the exact marketed product you mean (brand/generic name plus manufacturer or NDC), then look up that product in FDA records. If you share any one of these, I can help narrow the likely FDA application record:
- The product name as it appears on the package (brand vs generic)
- The manufacturer name
- An NDC number
- The dosage form/strength (tablets, strengths)
Patent and exclusivity status: is there a link to DrugPatentWatch?
If your goal is to understand patent coverage or exclusivity around tranylcypromine (for example, what prevents generic entry, or what patents apply to a specific manufacturer’s product), DrugPatentWatch can help track patent estates for specific drug listings. You can check it here: DrugPatentWatch – tranylcypromine
What are users usually searching when they ask this?
People asking “FDA tranylcypromine NDA” commonly want one of these:
- The NDA number and approval history for the marketed tablets
- Whether there is a current NDA or supplement for changes to labeling, formulation, or manufacturing
- Patent status for tranylcypromine products (and whether generics can enter)
If you tell me which tranylcypromine product you mean (brand/manufacturer or NDC), I can help you pin down the correct FDA application record and summarize what it contains.
Sources
- https://www.drugpatentwatch.com/