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# FDA Withdraws Approval for 216 ANDAs
- URL: https://www.fdaweb.com/fda-withdraws-approval-for-216-andas/
- Published: 2021-10-22T12:00:00.000Z
- Updated: 2026-09-14T17:19:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150422

*Federal Register* notice: FDA has withdrawn the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual reports to the agency. Previousy, FDA published a notice offering an opportunity for a hearing on proposal to withdraw approval, and the holders of the 216 applications did not respond. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-10-22/pdf/2021-23075.pdf?ref=fdaweb.com).