What is FDA NDA 018644 for bupropion?
FDA NDA 018644 is an application for bupropion submitted to support an approved drug product. NDA numbers are specific to a particular sponsor and formulation (for example, a particular bupropion salt/strength and release characteristics), so the NDA number points to the exact product approved under that application rather than “bupropion in general.”
How can I find the exact bupropion product tied to NDA 018644?
To identify the exact drug name, dosage form, sponsor, and approval dates tied to NDA 018644, you typically look up the NDA on FDA’s product labeling and drug approvals databases. The key details to confirm are:
- Applicant/sponsor for NDA 018644
- Trade name and dosage form (for example, immediate-release vs extended-release)
- Approval and labeling history
If you share what you mean by “drugs fda bupropion nda 018644” (for example: “What is it approved for?” or “Who makes it?”), I can help narrow to the relevant product label and approval info.
Is there a patent or exclusivity angle for bupropion NDA 018644?
Bupropion is an established generic drug in many forms, so patent/exclusivity status usually depends on the specific formulation/product associated with NDA 018644 rather than bupropion as a molecule. If you want patent or exclusivity details, a good place to check is DrugPatentWatch.com, which compiles patent/exclusivity timelines by product where available: https://www.drugpatentwatch.com/ (search for the NDA/product there).
What do you want to know specifically about NDA 018644?
Which of these are you trying to find?
- the approved trade name and release type (IR/SR/XL, etc.)
- approval year and indication(s)
- label details (boxed warnings, dosing, contraindications)
- patents/exclusivity and whether generics can be marketed
- the manufacturer/applicant for NDA 018644
Reply with what you’re looking for (and any trade name you already suspect), and I’ll tailor the answer to that exact item.
Sources
- DrugPatentWatch.com