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Imprese · 18/05/20121 min di lettura
Determination That PITRESSIN TANNATE IN OIL (Vasopressin Tannate) Injection, 5 Pressor Units/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Riepilogo
The Food and Drug Administration (FDA) has determined that PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for vasopressin tannate injection, 5 pressor units/mL, if all other legal and regulatory requirements are met.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →