Imprese · 28/03/19941 min di lettura
Chelsea Laboratories, Inc.; Withdrawal of Approval of 26 Abbreviated New Drug Applications
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Riepilogo
The Food and Drug Administration (FDA) is withdrawing approval of 26 abbreviated new drug applications (ANDA's) held by Chelsea Laboratories, Inc., 896 Orlando Ave., West Hempstead, NY 11552 (Chelsea). Chelsea notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. EFFECTIVE DATE: April 27, 1994. FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug Evaluation and Research (HFD-360), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1038. SUPPLEMENTARY INFORMATION: Chelsea informed FDA that the drugs listed in the table in this document are no longer marketed and requested that FDA withdraw approval of the applications. Chelsea has also, by its request, waived its opportunity for a hearing.