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# CDER Proposes to Withdraw Bufferin NDA
- URL: https://www.fdaweb.com/cder-proposes-to-withdraw-bufferin-nda/
- Published: 2022-11-23T12:00:00.000Z
- Updated: 2026-09-14T18:07:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153258

*Federal Register* notice: CDER is proposing to withdraw the approval of an NDA 006499 for Bufferin (aspirin) tablets because it has not received required annual reports. The NDA was approved in 1948 and currently the agency says it has received conflicting information regarding the identity of the current NDA holder. It notes that the Bufferin withdrawal will not impact nonprescription aspirin products that are legally marketed without an approved application as over the counter monograph drugs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-11-23/pdf/2022-25516.pdf?ref=fdaweb.com).