[Federal Register Volume 62, Number 55 (Friday, March 21, 1997)]
[Notices]
[Page 13651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7187]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0095]
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of 49 New
Drug Applications, 9 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 March 27, 1996 (61 FR 13506).
The document announced the withdrawal of approval of 49 new drug
applications (NDA's), 9 abbreviated antibiotic applications (AADA's),
and 36 abbreviated new drug applications (ANDA's). The document
inadvertently withdrew approval of NDA 18-962 for Manganese Chloride
Injection held by Abbott Laboratories, D-389, Bldg. AP30, 200 Abbott
Park Rd., Abbott Park, IL 60064-3537. This document confirms that
approval of NDA 18-962 is still in effect, and that the withdrawal of
approval of the NDA was in error.
EFFECTIVE DATE: March 27, 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. 96-7309, appearing on page 13506 in the Federal Register
of Wednesday, March 27, 1996, the following correction is made: On page
13507, in the table, the entry for NDA 18-962 is removed.
Dated: March 14, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-7187 Filed 3-20-97; 8:45 am]
BILLING CODE 4160-01-F
