Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications; Correction, 37459 [2020-13346]
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37459
(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withdrawn effective November 2, 2018.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withdrawn effective November 2, 2018.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]
BILLING CODE 4164–01–P
[FR Doc. 2020–13345 Filed 6–19–20; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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[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.
-----------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
