Notice2023-15454
Bristol Myers Products Inc.; Withdrawal of Approval of a New Drug Application for BUFFERIN (Aspirin) Tablets
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for BUFFERIN (aspirin) tablets. The basis for the withdrawal is that the holder of the NDA has repeatedly failed to file required annual reports for this NDA.
Indexed from Federal Register on July 21, 2023.
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