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Entreprise · 28/07/20041 min de lecture
Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications; Correction
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Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →