Entreprise · 12/11/19961 min de lecture
Lilly Research Laboratories, et al.; Withdrawal of Approval of 12 New Drug Applications, 8 Abbreviated Antibiotic Applications, and 23 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 October 2, 1996 (61 FR 51457). The document announced the withdrawal of approval of 12 new drug applications (NDA's), 8 abbreviated antibiotic applications (AADA's), and 23 abbreviated new drug applications (ANDA's). That document inadvertently withdrew approval of all of NDA 18-830 for Tambocor (flecainide acetate) 50, 100, 150, and 200 milligrams (mg) tablets held by 3M Pharmaceuticals, 3M Center, Bldg. 270-3A-01, St. Paul, MN 55144- 1000. This notice confirms that approval of NDA 18-830 is still in effect, and approval is withdrawn only of portions pertaining to the 200 mg tablet.