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# FDA Withdrawing 249 ANDAs Over Annual Reports
- URL: https://www.fdaweb.com/fda-withdrawing-249-andas-over-annual-reports/
- Published: 2020-01-09T12:00:00.000Z
- Updated: 2026-09-14T15:58:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145803

*Federal Register* notice: FDA is proposing to withdraw approval of 249 ANDAs from multiple companies because they have repeatedly failed to file required annual reports for the applications. The ANDA holders are being offered an opportunity to request a hearing on the withdrawal proposal and they have until 2/10 to file a hearing request. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-09/pdf/2020-00120.pdf?ref=fdaweb.com).