Document ID: FDA-2015-N-3432-0002
Agency: fda
Document Type: Notice
Title: Organon USA et al.; Withdrawal of Approval of 67 New Drug Applications
and 128 Abbreviated New Drug Applications; Correction
Posted Date: 2016-06-06T04:00Z

[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Page 36310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13182]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3432]

Organon USA et al.; Withdrawal of Approval of 67 New Drug 
Applications and 128 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 13, 2015 (80 FR 
61426). The document announced the withdrawal of approval of 67 new 
drug applications (NDAs) and 128 abbreviated new drug applications from 
multiple applicants, effective November 12, 2015. The document 
indicated that FDA was withdrawing approval of the following two NDAs 
after receiving a request from the NDA holder, Merck Sharp & Dohme 
Corp. (Merck), 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889: 
NDA 016096, MINTEZOL (thiabendazole) Tablets, and NDA 016097, MINTEZOL 
(thiabendazole) Oral Suspension. Before withdrawal of these NDAs became 
effective, Merck informed FDA that it did not want approval of the NDAs 
withdrawn. Because Merck timely requested that approval of these NDAs 
not be withdrawn, the approval of NDAs 016096 and 016097 is still in 
effect.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, October 
13, 2015, appearing on page 61426 in FR Doc. 2015-25922, the following 
correction is made:
    On page 61426, in table 1, the entries for NDAs 016096 and 016097 
are removed.

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13182 Filed 6-3-16; 8:45 am]
 BILLING CODE 4164-01-P