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Entreprise · 19/10/20111 min de lecture
Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 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 February 11, 2009 (74 FR 6896). The document withdrew approval of 103 new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs) from multiple applicants. The document inadvertently withdrew approval of NDA 50-435 for GEOCILLIN (carbenicillin indanyl sodium) Tablets held by Pfizer, Inc., 235 East 42d St., New York, NY 10017. FDA confirms that approval of NDA 50-435 is still in effect.
Langue originale de la source: Federal Register — Health and Human ServicesOuvrir le communiqué original →