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Entreprise · 06/06/20231 min de lecture
Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated 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 July 19, 2013. The document announced the withdrawal of approval of 52 new drug applications (NDAs) and 77 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 19, 2013. The document erroneously included the withdrawal of ANDA 075328 for Pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811. This notice corrects that error.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →