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Entreprise · 03/10/20251 min de lecture
Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications; Correction
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Résumé
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on August 4, 2025 (90 FR 36440). The document announced the withdrawal of approval of 39 new drug applications (NDA) from multiple applicants, withdrawn as of September 3, 2025. The document erroneously included NDA number 021290. The correct NDA number is 020212 for Zinecard (dexrazoxane hydrochloric acid (HCl)) Injectable, equivalent to (EQ) 250 milligrams (mg) base/ vial and EQ 500 mg base/vial. This document corrects that error.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →