Deze vertaling wordt voorbereid. Voorlopig tonen we de oorspronkelijke Engelse versie.
Bedrijven · 9-9-20151 min lezen
Determination That GLUCAGON (Glucagon Hydrochloride) for Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10 Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Lokale automatische vertaling · Oorspronkelijke brontaal
Samenvatting
The Food and Drug Administration (FDA) has determined that GLUCAGON (glucagon hydrochloride) for injection, equivalent to (EQ) 1 milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for glucagon hydrochloride for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, if all other legal and regulatory requirements are met.
Oorspronkelijke brontaal: Federal Register — Food and Drug AdministrationOrigineel bericht openen →