What does “Drugs@FDA bupropion NDA 018644” refer to?
“Drugs@FDA” is FDA’s database of drug review documents and approval information. “NDA 018644” is the specific FDA application number tied to the approval review package for bupropion under that listing. The key thing to look up in that record is the approval date, dosage form/strength, and the specific label revisions tied to the NDA entry.
If you want, share the exact bupropion product name shown on the Drugs@FDA page (for example, whether it’s for immediate-release, sustained-release, or extended-release). Different bupropion formulations can appear under different NDA numbers, so the product name helps ensure you’re reading the right approval.
How can I find the approval date, label, and review documents on Drugs@FDA?
In the Drugs@FDA entry for NDA 018644, the pages typically connect the application to:
- the approval history (including approval date),
- the “Label Information” or prescribing information versions tied to that approval,
- key review documents (like medical review, pharmacology/toxicology review when available),
- and—if applicable—post-marketing labeling supplements.
Is there a patent or exclusivity story for bupropion NDA 018644?
Patent and exclusivity details depend on the exact bupropion product and formulation tied to NDA 018644, and they can vary by strength, dosage form, and whether the approval is tied to a particular brand. A fast way to check related patent/exclusivity listings is DrugPatentWatch.com, which aggregates patent and regulatory timelines for specific products.
You can search there for the exact “NDA 018644” product entry: https://www.drugpatentwatch.com/
Why might the NDA number matter for generic availability?
NDA numbers are tied to the original FDA approval package for a specific product/formulation. Generic entry timing often depends on:
- when the reference product’s patents expire (if any are listed for that product),
- whether regulatory exclusivities (like Hatch-Waxman exclusivity, when applicable) have lapsed,
- and whether later supplements changed the formulation or protected features.
Because bupropion has multiple formulations across time, the NDA number is the best anchor for matching the right protections and review history.
What should I search next if I want the specific bupropion product?
If your goal is to identify the exact product name, dosage form, and how that NDA maps to current labeling, the most efficient next step is:
1) open the Drugs@FDA page for NDA 018644, and
2) copy the product name shown there, then search for that same product on label/prescribing information pages.
If you paste the product name or a link to the Drugs@FDA page text you’re seeing, I can tell you what that NDA entry corresponds to and what the listing indicates.
Sources cited
- https://www.drugpatentwatch.com/