comments last updated: August 8, 2024
In the WeedsDocument ID FDA-2024-N-3271-0001
Federal Register ID 2024-17515
Docket ID FDA-2024-N-3271
Want to get even more in the weeds?
Explore supplementary materials on regulations.govThe Food and Drug Administration's FDA or Agency Center for Drug Evaluation and Research CDER is proposing to withdraw approval of two abbreviated new drug applications ANDAs and is announcing an opportunity for the ANDA holder to request a hearing on this proposal. The basis for the proposal is that the ANDA holder has repeatedly failed to file required annual reports for those ANDAs.