Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications; Correction

Summary

The US Food and Drug Administration (FDA) is correcting a notice that announced the voluntary withdrawal of approval of four abbreviated new drug applications (ANDAs) from two applicants, including Sun Pharmaceutical Industries, Ltd. The withdrawal was initially set to take effect on April 13, 2018, but Sun Pharmaceutical requested that the approval of one of the ANDAs not be withdrawn, resulting in the approval remaining in effect.