97-19012. Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug Applications, 13 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications; Correction

[Federal Register Volume 62, Number 139 (Monday, July 21, 1997)]
[Notices]
[Page 39003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 87N-0262]


Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug 
Applications, 13 Abbreviated Antibiotic Applications, and 46 
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 June 25, 1997 (62 FR 34297). 
The document announced the withdrawal of approval of 39 new drug 
applications (NDA's), 13 abbreviated antibiotic applications (AADA's), 
and 46 abbreviated new drug applications (ANDA's). The document 
inadvertently withdrew approval of NDA 50-678 for DYNABAC 
(dirithromycin tablets) held by Lilly Research Laboratories, Lilly 
Corporate Center, Indianapolis, IN 46285. This document confirms that 
approval of NDA 50-678 is still in effect, and that the withdrawal of 
approval of the NDA was in error.

EFFECTIVE DATE: June 25, 1997.

FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 1451 
Rockville Pike, Rockville, MD 20852, 301-594-2041.

    In FR Doc. 97-16609 appearing on page 34297 in the issue of 
Wednesday, June 25, 1997, the following correction is made: On page 
34298, in the table, the entry for NDA 50-678 is removed.

    Dated: July 11, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-19012 Filed 7-18-97; 8:45 am]
BILLING CODE 4160-01-F