Document ID: FDA-2012-N-0563-0002
Agency: fda
Document Type: Notice
Title: Enforcement Action Dates: Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Correction
Posted Date: 2012-07-13T04:00Z

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41415-41416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17089]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0563]

Single-Ingredient, Immediate-Release Drug Products Containing 
Oxycodone for Oral Administration and Labeled for Human Use; 
Enforcement Action Dates; 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 July 6, 2012 (77 FR 40069). 
The document announced FDA's intention to take enforcement action 
against all unapproved single-ingredient, immediate-release drug 
products that contain oxycodone hydrochloride for oral administration 
and are labeled for human use, and persons who manufacture or cause the 
manufacture or distribution of such products in interstate commerce. 
The document was published with an incorrect Web link. This document 
corrects that error.

[[Page 41416]]

FOR FURTHER INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5368, Silver Spring, MD 20993-0002, 301-
796-3485, astrid.lopezgoldberg@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. 2012-16475, appearing on page 
40069 in the Federal Register of Friday, July 06, 2012, the following 
correction is made:
    1. On page 40070, in the first column, in the last paragraph, the 
Web link ``http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm'' is 
corrected to read ``http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm#narcotics''.

    Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17089 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P