Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 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 June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 6, 2026. The document indicated that FDA was withdrawing approval of ANDA 207366 for ribavirin solution, 6 grams/vial, held by Navinta LLC, 1499 Lower Ferry Rd., Ewing, NJ 08618; ANDA 212957 for fosaprepitant dimeglumine powder, Equivalent to (EQ) 150 milligrams (mg) base/vial, held by Navinta LLC; and ANDA 218638 for nicardipine hydrochloride (HCl) capsule, 20 mg and 30 mg, held by Navinta LLC. Before FDA withdrew the approval of these ANDAs, Navinta LLC informed FDA that they did not want the approval of the ANDAs withdrawn. Because Navinta LLC timely requested that approval of the ANDAs not be withdrawn, the approval is still in effect. This notice removes the entries for ANDA 207366, ANDA 212957, and ANDA 218638.
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<title>Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026)</title>
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[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Notices]
[Page 64652]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20730]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-5816]
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16
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 June 3, 2026. The document
announced the withdrawal of approval of 16 abbreviated new drug
applications (ANDAs) from multiple applicants, withdrawn as of July 6,
2026. The document indicated that FDA was withdrawing approval of ANDA
207366 for ribavirin solution, 6 grams/vial, held by Navinta LLC, 1499
Lower Ferry Rd., Ewing, NJ 08618; ANDA 212957 for fosaprepitant
dimeglumine powder, Equivalent to (EQ) 150 milligrams (mg) base/vial,
held by Navinta LLC; and ANDA 218638 for nicardipine hydrochloride
(HCl) capsule, 20 mg and 30 mg, held by Navinta LLC. Before FDA
withdrew the approval of these ANDAs, Navinta LLC informed FDA that
they did not want the approval of the ANDAs withdrawn. Because Navinta
LLC timely requested that approval of the ANDAs not be withdrawn, the
approval is still in effect. This notice removes the entries for ANDA
207366, ANDA 212957, and ANDA 218638.
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#034e6271776b622d4d64767a666d436567622d6b6b702d646c75"><span class="__cf_email__" data-cfemail="dc91bdaea8b4bdf292bba9a5b9b29cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of Wednesday, June
3, 2026 (91 FR 33185), appearing on page 33185 in FR Doc. 2026-11062,
the following correction is made:
On page 33185, in the table, the entries for ANDA 207366, ANDA
212957, and ANDA 218638 are removed.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20730 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P
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