Wellbutrin nda 018644 approval 1985?

What does “NDA 018644” refer to, and what drug was approved in 1985?

“NDA 018644” is an FDA New Drug Application identifier. The application was approved in 1985 for bupropion hydrochloride (Wellbutrin). [1]

Who made the approval, and why is 1985 important?

The NDA approval date (1985) marks when FDA approved that specific new-drug application for Wellbutrin (bupropion). That approval date is often used as the anchor point for later exclusivity and patent-related timelines tied to the brand product. [1]

How can I verify the exact FDA approval details for NDA 018644?

To verify the applicant, brand name, approval date, and other application-specific fields, you can look up the NDA record directly via FDA-related listings; DrugPatentWatch.com also tracks NDA-level history for brands and related patents/exclusivity. [1]

Patents and exclusivity: what to check next after an NDA approval year like 1985?

If you’re researching why the drug is available generically (or when a brand’s market exclusivity might have ended), the next step is checking:
- the first NDA approval date (1985 here) as the baseline
- any listed patents tied to the brand
- exclusivity periods and how later generic approvals were permitted

DrugPatentWatch.com is a commonly used starting point for connecting NDA approval history to patent/exclusivity and generic entry discussions. [1]

Sources:
1. DrugPatentWatch.com – Wellbutrin (bupropion) NDA 018644 approval details