Document ID: FDA-2017-N-3203-0002
Agency: fda
Document Type: Notice
Title: Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications; Correction
Posted Date: 2018-02-27T05:00Z

[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Page 8485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03925]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3203]

Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 
New Drug Applications and 161 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 21, 2017 (82 FR 28322). 
The document announced the withdrawal of approval of 121 new drug 
applications (NDAs) and 161 abbreviated new drug applications from 
multiple applicants, withdrawn as of July 21, 2017. The document 
indicated that FDA was withdrawing approval of NDA 204508, Clinolipid 
20% (olive oil and soybean oil) USP, 16%/4%, after receiving a request 
from the NDA holder, Baxter Healthcare Corp. (Baxter), 32650 N Wilson 
Rd., Round Lake, IL 60073. Before the approval of NDA 204508 was 
withdrawn, Baxter informed FDA that it did not want the approval of 
this NDA withdrawn. Because Baxter timely requested that approval of 
this NDA not be withdrawn, the approval of NDA 204508 is still in 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 Wednesday, June 
21, 2017, appearing on page 28322 in FR Doc. 2017-12908, the following 
correction is made:
    On page 28329, in table 1, the entry for NDA 204508 is removed.

    Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03925 Filed 2-26-18; 8:45 am]
 BILLING CODE 4164-01-P