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# Bufferin NDA Withdrawn by FDA
- URL: https://www.fdaweb.com/bufferin-nda-withdrawn-by-fda/
- Published: 2023-07-21T12:00:00.000Z
- Updated: 2026-09-14T18:45:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154928

*Federal Register* notice: FDA is withdrawing approval of an NDA for Bufferin (aspirin) tablets because the application holder has failed to file required annual reports. The NDA holder identified in FDA’s records is Bristol Myers Products, but the agency says it has received conflicting information in its attempts to confirm the true holder’s identity. Additionally, the agency says that the NDA product Bufferin has not been marketed for many years, and another buffered aspirin drug product using the same trade name, but with a different formulation, is currently being marketed as an over the counter monograph drug. FDA says that its withdrawal of the Bufferin NDA does not impact any nonprescription aspirin products that are legally marketed under the drug monograph process. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-07-21/pdf/2023-15454.pdf?ref=fdaweb.com).