Withdrawal of Approval of Drug Application: Celgene Corporation and Teva Pharmaceutical Industries, Ltd.; Peripheral T-Cell Lymphoma Indication for ISTODAX (Romidepsin) for Injection and Romidepsin Injection

TitleWithdrawal of Approval of Drug Application: Celgene Corporation and Teva Pharmaceutical Industries, Ltd.; Peripheral T-Cell Lymphoma Indication for ISTODAX (Romidepsin) for Injection and Romidepsin Injection
ToC Doc Celgene Corporation and Teva Pharmaceutical Industries, Ltd.; Peripheral T-Cell Lymphoma Indication for ISTODAX (Romidepsin) for Injection and Romidepsin Injection
Docket Number2022-09889
Type Notice
Subject Withdrawal of Approval of Drug Application:
Celgene Corporation and Teva Pharmaceutical Industries, Ltd.; Peripheral T-Cell Lymphoma Indication for ISTODAX (Romidepsin) for Injection and Romidepsin Injection
Publication Date2022-05-09
Last Updated Date 2022-05-06 08:15:10 -0400
Last Public Inspection2022-05-06
Filed At2022-05-06T08:45:00.000-04:00
PDF 2022-09889_PI.pdf (59810 bytes)
Download TXT / HTML / JSON
Number of Pages 3
Filing Typeregular
AgenciesFood and Drug Administration

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