Zdrowie i gospodarka · 21/11/2008
FDA Clears Path for Nalbuphine Hydrochloride Injection, 10 and 20 mg/ml, to be Approved via Abbreviated New Drug Applications (ANDAs)
The FDA has determined that Nalbuphine Hydrochloride Injection, 10 and 20 mg/ml, was not withdrawn from sale due to safety or effectiveness concerns, paving the way for potential approval of abbreviated new drug applications (ANDAs) for this product.
Source: Federal Register — Food and Drug AdministrationOpen original release →