The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of a new drug application (NDA) for Dextrose 5% Injection in Plastic Container, 5 grams (g)/100 milliliters (mL), held by DHL Laboratories Inc., 155 Medical Science Dr., Union, SC 23979, and is announcing an opportunity for the holder of the NDA to request a hearing on this proposal. The basis for the proposal is that the holder of the NDA has repeatedly failed to file required annual reports for the NDA.
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DHL Laboratories Inc.; Proposal To Withdraw Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container; Opportunity for a Hearing
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of a new drug application (NDA) for Dextrose ...
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83 FR 44056
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“DHL Laboratories Inc.; Proposal To Withdraw Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container; Opportunity for a Hearing,” thefederalregister.org (August 29, 2018), https://thefederalregister.org/documents/2018-18749/dhl-laboratories-inc-proposal-to-withdraw-approval-of-a-new-drug-application-for-dextrose-5-injection-in-plastic-contain.