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Negócios · 28/07/20041 min de leitura
Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 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 May 5, 2004 (69 FR 25124). The document announced the withdrawal of approval of 92 new drug applications (NDAs) and 49 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of ANDA 88-584 for DHCplus (dihydrocodeine bitartrate, acetaminophen, and caffeine) Capsules, 356.4 milligrams, held by Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431. FDA confirms that approval of ANDA 88-584 is still in effect.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →