The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs) held by Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical). These drug products are no longer marketed, and Sun Pharmaceutical has requested that the approval of the applications be withdrawn.
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Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of Three Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs) held by Sun Pharmaceutical Industries, Ltd., c/o Sun ...
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83 FR 19787
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“Sun Pharmaceutical Industries, Ltd.; Withdrawal of Approval of Three Abbreviated New Drug Applications,” thefederalregister.org (May 4, 2018), https://thefederalregister.org/documents/2018-09533/sun-pharmaceutical-industries-ltd-withdrawal-of-approval-of-three-abbreviated-new-drug-applications.