Notice2026-11062
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications
Primary source
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Published
June 3, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 91 Issue 106 (Wednesday, June 3, 2026)</title>
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[Federal Register Volume 91, Number 106 (Wednesday, June 3, 2026)]
[Notices]
[Page 33185]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11062]
[[Page 33185]]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 16 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 6, 2026.
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#55183427213d347b1b32202c303b153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="cc81adbeb8a4ade282abb9b5a9a28caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The applicants listed in table 1 have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application
under Sec. 314.150(c) is without prejudice to refiling.
Table 1--ANDAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040227............... Phentermine Elite Laboratories,
hydrochloride (HCl) Inc., 165/144/135
capsule, 30 Ludlow Ave.,
milligrams (mg). Northvale, NJ 07647.
ANDA 040460............... Phentermine HCl Do.
capsule, 15 mg.
ANDA 065025............... Cyclosporine AbbVie Inc., 1 N
solution, 100 mg/ Waukegan Rd., North
milliliters (mL). Chicago, IL 60064.
ANDA 075180............... Ranitidine HCl Par Health USA LLC,
tablet, Equivalent U.S. Agent for PH
to (EQ) 150 mg and Health Limited, 300
EQ 300 mg. Tice Blvd., Suite
230, Woodcliff Lake,
NJ 07677.
ANDA 076434............... PAROEX (chlorhexidine Sunstar Americas,
gluconate) solution, Inc., 301 E Central
0.12%. Rd., Schaumburg, IL
60195.
ANDA 090734............... OXYCODONE AND Par Health USA LLC,
ACETAMINOPHEN U.S. Agent for PH
(acetaminophen; Health Limited, 9
oxycodone HCl) Great Valley
tablet, 325 mg; 7.5 Parkway, Malvern, PA
mg and 325 mg; 10 mg. 19355.
ANDA 204960............... Cisatracurium eVenus Pharmaceutical
besylate injectable, Lab Inc., U.S. Agent
EQ 2 mg base/mL, for Jiangsu Hengrui
CISATRACURIUM Pharmaceuticals Co.,
BESYLATE Ltd., 506 Carnegie
PRESERVATIVE FREE Center, Suite 102,
(cisatracurium Princeton, NJ 08540.
besylate) injectable
EQ 2 mg base/mL and
EQ 10 mg base/mL.
ANDA 206159............... DEXTROAMP SACCHARATE, Par Health USA LLC,
AMP ASPARTATE, U.S. Agent for PH
DEXTROAMP SULFATE Health Limited.
AND AMP SULFATE
(amphetamine
aspartate;
amphetamine sulfate;
dextroamphetamine
saccharate;
dextroamphetamine
sulfate) (extended-
release capsule,
1.25 mg; 1.25 mg;
1.25 mg; 1.25 mg,
2.25 mg; 2.25 mg;
2.25 mg; 2.25 mg,
3.75 mg; 3.75 mg;
3.75 mg; 3.75 mg, 5
mg; 5 mg; 5 mg; 5
mg, 6.25 mg; 6.25
mg; 6.25 mg; 6.25
mg, and 7.5 mg; 7.5
mg; 7.5 mg; 7.5 mg.
ANDA 207366............... Ribavirin solution, 6 Navinta LLC, 1499
grams/vial. Lower Ferry Rd.,
Ewing, NJ 08618.
ANDA 210653............... Clomipramine HCl PTS Consulting, LLC,
capsule, 25 mg, 50 U.S. Agent for TP
mg, and 75 mg. ANDA HOLDINGS, LLC.,
6739 Valhalla Ct.,
Shawnee, KS 66217.
ANDA 210948............... Albuterol sulfate Makro Technologies
tablet, EQ 2 mg base Inc., (Makrocare)
and EQ 4 mg base. U.S. Agent for
Aizant Drug Research
Solutions Private
Limited, 116 Village
Blvd., Suite # 200,
Princeton, NJ 08540.
ANDA 211538............... Vasopressin solution, Eagle
20 units/mL. Pharmaceuticals,
Inc., 50 Tice Blvd.,
Suite 315, Woodcliff
Lake, NJ 07677.
ANDA 212106............... Entecavir tablet, 0.5 CMC GMP LLC, U.S.
mg and 1 mg. Agent for Pharmadax
Inc., 9805 NE 116th
St. PMB #A255,
Kirkland, WA 98034.
ANDA 212957............... Fosaprepitant Navinta LLC.
dimeglumine powder,
EQ 150 mg base/vial.
ANDA 214423............... Venlafaxine HCl CMC GMP LLC, U.S.
extended-release Agent for Pharmadax
tablet, EQ 75 mg Inc.
base and EQ 150 mg
base.
ANDA 218638............... Nicardipine HCl Navinta LLC.
capsule, 20 mg and
30 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of July 6,
2026. Approval of each entire application is withdrawn, including any
strengths and dosage forms inadvertently missing from table 1.
Introduction or delivery for introduction into interstate commerce of
products listed in table 1 without an approved abbreviated new drug
application violates sections 505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products
that are listed in table 1 that are in inventory on July 6, 2026 may
continue to be dispensed until the inventories have been depleted or
the drug products have reached their expiration dates or otherwise
become violative, whichever occurs first.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11062 Filed 6-2-26; 8:45 am]
BILLING CODE 4164-01-P
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