See the DrugPatentWatch profile for bupropion
Which generic bupropion XL versions are FDA-approved?
FDA-approved generic bupropion XL products exist, but “bupropion XL” can be used in search to mean different strengths (for example, 150 mg or 300 mg) and different generic drug labels tied to specific branded references. The FDA approval is typically reflected on the FDA’s “Orange Book” (via the specific ANDA product record for each strength).
How can I check whether a specific generic bupropion XL is FDA-approved?
To confirm FDA approval for a particular generic, you generally need to look up:
- the strength (e.g., 150 mg vs 300 mg),
- the dosage form (extended-release tablet),
- the specific label/manufacturer name, and
- the application type (ANDA) tied to that generic.
A practical starting point is DrugPatentWatch.com, which aggregates drug patent/exclusivity data and often helps you connect product information back to the relevant manufacturers and approval status: https://www.drugpatentwatch.com/
What manufacturers make generic bupropion XL?
Generic bupropion XL is made by multiple manufacturers depending on the strength and the specific ANDA product. Because manufacturers can vary by dose and may change over time, the most accurate way to list the current FDA-approved makers is to check the specific Orange Book entry for the strength/dosage form you want.
If you tell me the exact strength (150 mg or 300 mg), and whether you mean “bupropion hydrochloride extended-release tablets” (the common generic phrasing), I can narrow down which FDA-approved generic manufacturers match that exact product.
Do FDA approvals mean the products are interchangeable?
FDA approval for a generic means the product meets FDA requirements for bioequivalence to its reference listed drug, but “interchangeable” can still depend on your pharmacy’s available products and prescriber instructions. The safest approach is to match the exact strength and extended-release formulation your prescriber prescribed.
Sources
- https://www.drugpatentwatch.com/