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# FDA Withdrawing Watson Labs Oxycodone Hydrochloride
- URL: https://www.fdaweb.com/fda-withdrawing-watson-labs-oxycodone-hydrochloride/
- Published: 2019-10-29T12:00:00.000Z
- Updated: 2026-09-15T01:59:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145358

*Federal Register* notice: FDA is proposing to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this action. The basis for the proposal is that the company has repeatedly failed to submit required data to support a finding of bioequivalence for this ANDA. Previous bioanalytical studies to support the ANDA were conducted by Cetero Research, which was found to be engaged in improper conduct (document falsification and sample manipulation). After requesting new bioequivalence data, Watson notified the agency that the product is no longer marketed. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-28/pdf/2019-23490.pdf?ref=fdaweb.com).