Is diflunisal currently FDA-approved?
Diflunisal is an FDA-approved drug. It has an established approval history in the United States as an NSAID used for pain and inflammation.
What strength(s) and brand names are available in the US?
The commonly referenced US product is diflunisal under the brand Dolobid (diflunisal). Availability can vary by manufacturer and pharmacy supply, but the drug itself remains FDA-approved.
Has diflunisal’s FDA status changed recently (withdrawn, discontinued, or reapproved)?
There has not been a widely documented change described here indicating that diflunisal was withdrawn from FDA approval. If you’re checking for a specific manufacturer’s product availability, FDA approval can remain, while individual labels/NDAs can change due to sourcing or discontinuations.
How can I verify the exact FDA approval (and which product label) for diflunisal?
To confirm the current FDA-approved labeling and product details, look up diflunisal’s listing in the FDA’s drug databases (for example, the Drugs@FDA database) and compare the most recent approved label with the specific manufacturer/NDC your pharmacy uses.
What does FDA approval mean for patients using diflunisal?
FDA approval means the drug’s labeling (indications, dosing, contraindications, warnings, and safety information) has been reviewed for safety and effectiveness based on submitted data and the approved product history. Patients should still follow the approved label and prescriber guidance for NSAID risks (including cardiovascular and gastrointestinal effects).
Sources
I don’t have access to FDA databases or current web results in this environment, so I can’t cite the specific FDA Drugs@FDA record here. If you want, share the exact diflunisal product name (brand/NDC or manufacturer) you’re looking at, and I can tell you what to look for on the FDA page (and how to interpret the label/status fields).