Parke-Davis Pharmaceutical Research et al.; Withdrawal of Approval of 14 New Drug Applications and 13 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 September 25, 1998 (63 FR 51359). The document announced the withdrawal of approval of 14 new drug applications and 13 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of ANDA 80-025 for Sulf-10 (sulfacetamide sodium ophthalmic solution, USP) 10% held by Ciba Vision, 11460 Johns Creek Pkwy., Duluth, GA 30097-1556. FDA confirms that approval of ANDA 80-025 is still in effect.

EFFECTIVE DATE:

September 25, 1998.

FOR FURTHER INFORMATION CONTACT:

Olivia A. Pritzlaff, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

In FR Doc. 98-25713 appearing on page 51359 in the issue of Friday, September 25, 1998, the following correction is made: On page 51360, in the table, the entry for ANDA 80-025 is removed.