[Federal Register Volume 62, Number 205 (Thursday, October 23, 1997)]
[Notices]
[Page 55267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28012]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0399]
Helen A. Ballack Co. et al.; Withdrawal of Approval of 61 New
Drug Applications, 8 Abbreviated Antibiotic Applications, and 36
Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of September 25, 1997 (62 FR
50387). The document announced the withdrawal of approval of 61 new
drug applications (NDA's), 8 abbreviated antibiotic applications
(AADA's), and 36 abbreviated new drug applications (ANDA's). The
document inadvertently withdrew approval of NDA 19-339 for Heparin
Sodium in 5% Dextrose Injection in CR3 Flexible Container held by
Abbott Laboratories, D-389 Bldg. AP30, 200 Abbott Park Rd., Abbott
Park, IL 60064-3537. This document confirms that approval of NDA 19-339
is still in effect, and that the withdrawal of approval of the NDA was
in error.
EFFECTIVE DATE: September 25, 1997.
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. 97-25369, appearing at page 50387 in the Federal
Register of Thursday, September 25, 1997, the following correction is
made: On page 50388, in the table, the entry for NDA 19-339 is removed.
Dated: October 9, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-28012 Filed 10-22-97; 8:45 am]
BILLING CODE 4160-01-F
