[Federal Register: July 28, 2004 (Volume 69, Number 144)]
[Page 45068]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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]