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Negócios · 10/04/20011 min de leitura
Parke-Davis Pharmaceutical Research et al.; Withdrawal of Approval of 14 New Drug Applications and 13 Abbreviated New Drug Applications; Correction
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Resumo
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 25, 1998 (63 FR 51359). The document announced the withdrawal of approval of 14 new drug applications and 13 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of ANDA 80-025 for Sulf-10 (sulfacetamide sodium ophthalmic solution, USP) 10% held by Ciba Vision, 11460 Johns Creek Pkwy., Duluth, GA 30097-1556. FDA confirms that approval of ANDA 80-025 is still in effect.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →