Notices. Notice; correction
231 words·~1 min read·
/register/2004/07/28/04-17110·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4168-17-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0159] Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: 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. DATES: The notice published on May 5, 2004 (69 FR 25124) as corrected by this document has a date of June 4, 2004. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. In FR Doc. 04-10194 appearing on page 25124 in the issue of Wednesday, May 5, 2004, the following correction is made: On page 25130, in the table, the entry for NDA 88-584 is removed. Dated: June 2, 2004. Steven Galson, Acting Director, Center for Drug Evaluation and Research. [FR Doc. 04-17110 Filed 7-27-04; 8:45 am]