[Federal Register Volume 61, Number 219 (Tuesday, November 12, 1996)]
[Notices]
[Page 58071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28931]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0340]


Lilly Research Laboratories, et al.; Withdrawal of Approval of 12 
New Drug Applications, 8 Abbreviated Antibiotic Applications, and 23 
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 October 2, 1996 (61 FR 51457). 
The document announced the withdrawal of approval of 12 new drug 
applications (NDA's), 8 abbreviated antibiotic applications (AADA's), 
and 23 abbreviated new drug applications (ANDA's). That document 
inadvertently withdrew approval of all of NDA 18-830 for Tambocor 
(flecainide acetate) 50, 100, 150, and 200 milligrams (mg) tablets held 
by 3M Pharmaceuticals, 3M Center, Bldg. 270-3A-01, St. Paul, MN 55144-
1000. This notice confirms that approval of NDA 18-830 is still in 
effect, and approval is withdrawn only of portions pertaining to the 
200 mg tablet.

EFFECTIVE DATE: October 2, 1996.

FOR FURTHER INFORMATION CONTACT:  Olivia A. Vieira, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1046.
    In FR Doc. 96-25198, appearing on page 51457 in the Federal 
Register of Wednesday, October 2, 1996, the following correction is 
made: On page 51457, in the second column, in the table, the entry for 
NDA 18-830 is corrected to read ``Tambocor (flecainide acetate), 200 mg 
Tablets (only those portions of the NDA that deal with 200 mg 
tablets).''

    Dated: October 29, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-28931 Filed 11-8-96; 8:45 am]
BILLING CODE 4160-01-F