Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 16, 2001 (66 FR 43017). The document announced the withdrawal of approval of 51 new drug applications (NDAs) and 25 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of NDA 17-255 for DTPA (chelate) Multidose (kit for the preparation of Tc-99m pentetate injection) held by Nycomed Amersham Imaging, 101 Carnegie Center, Princeton, NJ 08540. FDA confirms that approval of NDA 17-255 is still in effect.
August 16, 2001.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. 01-20605 appearing on page 43017 in the Federal Register of Thursday, August 16, 2001, the following correction is made: On page 43018, in the table, the entry for NDA 17-255 is removed.Start Signature
Dated: October 11, 2001.
Director, Center for Drug Evaluation and Research.
[FR Doc. 01-27520 Filed 11-01-01; 8:45 am]
BILLING CODE 4160-01-S