Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction, 48623 [2019-19920]
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Federal Register / Vol. 84, No. 179 / Monday, September 16, 2019 / Notices
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Jkt 247001
Number: CMS–R–153 (OMB control
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Dated: September 11, 2019.
William N. Parham, III,
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[FR Doc. 2019–19967 Filed 9–13–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
48623
Dated: September 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19920 Filed 9–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–3347]
Medical Devices; Exemption From
Premarket Notification: Class II;
Powered Wheeled Stretcher; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
[Docket No. FDA–2019–N–0113]
The Food and Drug
Administration (FDA or Agency) is
announcing that it has received a
petition requesting exemption from the
premarket notification requirements for
powered wheeled stretchers. These
devices are battery-powered tables with
wheels that are intended for medical
purposes for use by patients who are
unable to propel themselves
independently and who must maintain
a prone or supine position for prolonged
periods because of skin ulcers or
contractures (muscle contractions). FDA
is publishing this notice to obtain
comments in accordance with
procedures established by the Federal
Food, Drug, and Cosmetic Act (FD&C
Act).
SUMMARY:
Facta Farmaceutici S.p.A., et al.;
Withdrawal of Approval of 23
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 5, 2019. The
document announced the withdrawal of
approval of 23 abbreviated new drug
applications (ANDAs) from multiple
applicants, effective March 7, 2019. The
document erroneously included ANDA
077895 for Ursodiol Capsules USP, 300
milligrams, held by Impax Laboratories,
LLC. This notice corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jennifer Forde, Office of Regulatory
Policy, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6228, Silver Spring,
MD 20993, 301–348–3035.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of Tuesday,
February 5, 2019 (84 FR 1745), in FR
Doc. 2019–01129, the following
correction is made:
1. On page 1746, in the table, the
entry for ANDA 077895 is removed.
In a separate notice published in this
issue of the Federal Register, FDA is
withdrawing the approval of ANDA
077895 under 21 CFR 314.150(d).
PO 00000
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]]>Agencies
[Federal Register Volume 84, Number 179 (Monday, September 16, 2019)]
[Notices]
[Page 48623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19920]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0113]
Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23
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 5, 2019. The document
announced the withdrawal of approval of 23 abbreviated new drug
applications (ANDAs) from multiple applicants, effective March 7, 2019.
The document erroneously included ANDA 077895 for Ursodiol Capsules
USP, 300 milligrams, held by Impax Laboratories, LLC. This notice
corrects that error.
FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Office of Regulatory
Policy, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6228, Silver
Spring, MD 20993, 301-348-3035.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of Tuesday, February 5, 2019 (84 FR 1745),
in FR Doc. 2019-01129, the following correction is made:
1. On page 1746, in the table, the entry for ANDA 077895 is
removed.
In a separate notice published in this issue of the Federal
Register, FDA is withdrawing the approval of ANDA 077895 under 21 CFR
314.150(d).
Dated: September 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19920 Filed 9-13-19; 8:45 am]
BILLING CODE 4164-01-P
