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Imprese · 22/06/20201 min di lettura
Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications; Correction
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 12, 2019. The document announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The document erroneously included ANDA 077736 for Polyethylene Glycol 3350 Powder for Oral Solution, 17 grams/scoopful, held by Breckenridge Pharmaceutical, Inc. (Breckenridge). This document corrects that error.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →