Document ID: FDA-2019-N-0163-0004
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug
Applications; Correction
Posted Date: 2020-06-22T04:00Z

[Federal Register Volume 85, Number 120 (Monday, June 22, 2020)]
[Notices]
[Page 37459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13346]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0163]

Hospira, Inc., et al.; Withdrawal of Approval of 12 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 February 12, 2019. The 
document announced the withdrawal of approval of 12 abbreviated new 
drug applications (ANDAs) from multiple applicants. The document 
erroneously included ANDA 077736 for Polyethylene Glycol 3350 Powder 
for Oral Solution, 17 grams/scoopful, held by Breckenridge 
Pharmaceutical, Inc. (Breckenridge). This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 12, 2019 
(84 FR 3467), in FR Doc. 2019-02032, the following correction is made:
    1. On page 3467, in the table, the entry for ANDA 077736 is 
removed. The approval of ANDA 077736 was withdrawn effective November 
2, 2018.
    In the Federal Register of April 2, 2018 (83 FR 13994), FDA denied 
a hearing and issued an order withdrawing approval of multiple ANDAs 
for polyethylene glycol 3350, effective May 2, 2018. Breckenridge's 
ANDA 077736 was included in the April 2018 notice. In the Federal 
Register of July 30, 2018 (83 FR 36604), FDA subsequently published a 
notice granting a temporary stay of the effective date of the April 
2018 notice, extending the withdrawal of approval of the ANDAs to 
November 2, 2018. Thus, the approval of ANDA 077736 was withdrawn 
effective November 2, 2018.

    Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13346 Filed 6-19-20; 8:45 am]
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