Imprese · 25/09/20091 min di lettura
Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction
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Riepilogo
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 11, 2009 (74 FR 6896). The document announced the withdrawal of approval of 103 new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs). The document published with an error in the identification of the ANDA for Amiodarone Hydrochloride Injection, 50 milligrams/ milliliter, held by Hospira, Inc. This document corrects that error.