Food and Drug Administration, HHS.
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.
The notice published on May 5, 2004 (69 FR 25124) as corrected by this document has a date of June 4, 2004.Start Further Info
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.End Further Info
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.Start Signature
Dated: June 2, 2004.
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 04-17110 Filed 7-27-04; 8:45 am]
BILLING CODE 4160-01-S