Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction
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Abstract
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 14, 2025 (90 FR 49), appearing on page 12163 in FR Doc. 2025-04106. The document announced the withdrawal of approval of eight abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of April 14, 2025. The document indicated that FDA was withdrawing approval of the ANDA 075819 for amantadine hydrochloride syrup, 50 milligrams/5 milliliters, held by CMP Pharma, Inc., 8026 East Marlboro Rd., P.O. Box 147, Farmville, NC 27828. Before FDA withdrew the approval of this ANDA, CMP Pharma, Inc., 8026 East Marlboro Rd., P.O. Box 147, Farmville, NC 27828, informed FDA that they did not want the approval of the ANDA withdrawn. Because CMP Pharma, Inc., timely requested that approval of the ANDA not be withdrawn, the approval is still in effect. This notice corrects this error.
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<title>Federal Register, Volume 90 Issue 169 (Thursday, September 4, 2025)</title>
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[Federal Register Volume 90, Number 169 (Thursday, September 4, 2025)]
[Notices]
[Page 42767]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16905]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0124]
Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of
Eight 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 on March 14, 2025 (90 FR 49),
appearing on page 12163 in FR Doc. 2025-04106. The document announced
the withdrawal of approval of eight abbreviated new drug applications
(ANDAs) from multiple applicants, withdrawn as of April 14, 2025. The
document indicated that FDA was withdrawing approval of the ANDA 075819
for amantadine hydrochloride syrup, 50 milligrams/5 milliliters, held
by CMP Pharma, Inc., 8026 East Marlboro Rd., P.O. Box 147, Farmville,
NC 27828. Before FDA withdrew the approval of this ANDA, CMP Pharma,
Inc., 8026 East Marlboro Rd., P.O. Box 147, Farmville, NC 27828,
informed FDA that they did not want the approval of the ANDA withdrawn.
Because CMP Pharma, Inc., timely requested that approval of the ANDA
not be withdrawn, the approval is still in effect. This notice corrects
this error.
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, <a href="/cdn-cgi/l/email-protection#f1bc9083859990dfbf968488949fb1979590df999982df969e87"><span class="__cf_email__" data-cfemail="4f022e3d3b272e6101283a362a210f292b2e6127273c61282039">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, March 14,
2025 (90 FR 49), appearing on page 12163 in FR Doc. 2025-04106, the
following correction is made:
On page 12163, in the table, the entry for ANDA 075819 is removed.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16905 Filed 9-3-25; 8:45 am]
BILLING CODE 4164-01-P
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