Deze vertaling wordt voorbereid. Voorlopig tonen we de oorspronkelijke Engelse versie.
Bedrijven · 11-6-20191 min lezen
Determination That NIZORAL (Ketoconazole) Topical Cream, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Lokale automatische vertaling · Oorspronkelijke brontaal
Samenvatting
The Food and Drug Administration (FDA, Agency, or we) has determined that NIZORAL (ketoconazole) topical cream, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Oorspronkelijke brontaal: Federal Register — Food and Drug AdministrationOrigineel bericht openen →