Sandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications; Correction, 74968-74969 [2024-20873]
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Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices
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Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20891 Filed 9–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2803]
Sandoz Inc., et al.; Withdrawal of
Approval of 20 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 on June 21, 2024. The
document announced the withdrawal of
approval of 20 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of July 22,
2024. The document indicated that FDA
was withdrawing approval of the ANDA
076648 for nitrofurantoin
(monohydrate/macrocrystals) capsules,
75 milligrams (mg) and 25 mg, held by
Aurobindo Pharma USA Inc., 279
Princeton-Hightstown Rd., East
Windsor, NJ 08520; and the ANDA
090723 for duloxetine hydrochloride
capsules, delayed-release pellets,
Equivalent to (EQ) 20 mg base, EQ 30
mg base, and EQ 60 mg base, held by
Marksans Pharma, Inc., U.S. Agent for
Marksans Pharma Ltd., 150 Motor
Pkwy., Suite 401, 4th Floor, Rm. 430,
Hauppauge, NY 11788. Before FDA
withdrew the approval of these ANDAs,
Aurobindo Pharma USA Inc., and
Marksans Pharma, Inc., U.S. Agent for
Marksans Pharma Ltd., informed FDA
that they did not want the approval of
the ANDAs withdrawn. Because
Aurobindo Pharma USA Inc. and
Marksans Pharma, Inc., U.S. Agent for
Marksans Pharma Ltd., timely requested
that approval of their respective ANDAs
not be withdrawn, the approvals are still
in effect. This notice corrects these
errors.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 301–
796–3471, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Friday, June 21,
2024 (89 FR 52057), appearing on page
E:\FR\FM\13SEN1.SGM
13SEN1
Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices
52058 in FR Doc. 2024–13660, the
following correction is made:
On page 52058, in the table, the
entries for ANDA 076648 and ANDA
090723 are removed.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20873 Filed 9–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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Dated: September 10, 2024.
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[FR Doc. 2024–20884 Filed 9–12–24; 8:45 am]
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VerDate Sep<11>2014
17:53 Sep 12, 2024
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Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
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Committee Policy.
[FR Doc. 2024–20788 Filed 9–12–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
74969
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74968-74969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20873]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2803]
Sandoz Inc., et al.; Withdrawal of Approval of 20 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 on June 21, 2024. The document
announced the withdrawal of approval of 20 abbreviated new drug
applications (ANDAs) from multiple applicants, withdrawn as of July 22,
2024. The document indicated that FDA was withdrawing approval of the
ANDA 076648 for nitrofurantoin (monohydrate/macrocrystals) capsules, 75
milligrams (mg) and 25 mg, held by Aurobindo Pharma USA Inc., 279
Princeton-Hightstown Rd., East Windsor, NJ 08520; and the ANDA 090723
for duloxetine hydrochloride capsules, delayed-release pellets,
Equivalent to (EQ) 20 mg base, EQ 30 mg base, and EQ 60 mg base, held
by Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., 150
Motor Pkwy., Suite 401, 4th Floor, Rm. 430, Hauppauge, NY 11788. Before
FDA withdrew the approval of these ANDAs, Aurobindo Pharma USA Inc.,
and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd.,
informed FDA that they did not want the approval of the ANDAs
withdrawn. Because Aurobindo Pharma USA Inc. and Marksans Pharma, Inc.,
U.S. Agent for Marksans Pharma Ltd., timely requested that approval of
their respective ANDAs not be withdrawn, the approvals are still in
effect. This notice corrects these errors.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-
796-3471, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 21,
2024 (89 FR 52057), appearing on page
[[Page 74969]]
52058 in FR Doc. 2024-13660, the following correction is made:
On page 52058, in the table, the entries for ANDA 076648 and ANDA
090723 are removed.
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20873 Filed 9-12-24; 8:45 am]
BILLING CODE 4164-01-P
