Notice2026-20762
Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 9, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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
<html>
<head>
<title>Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Notices]
[Pages 64652-64654]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20762]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-10835]
Par Health USA LLC, U.S. Agent for PH Health Limited, et al.;
Withdrawal of Approval of 37 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 37 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the
[[Page 64653]]
drug products were no longer marketed and requested that the approval
of the applications be withdrawn.
DATES: Approval is withdrawn as of November 9, 2026.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#80cde1f2f4e8e1aecee7f5f9e5eec0e6e4e1aee8e8f3aee7eff6"><span class="__cf_email__" data-cfemail="b6fbd7c4c2ded798f8d1c3cfd3d8f6d0d2d798dedec598d1d9c0">[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 071230.................. Ibuprofen tablet, Par Health USA LLC,
300 milligrams (mg). U.S. Agent for PH
Health Ltd., 300
Tice Blvd., Suite
230, Woodcliff
Lake, NJ 07677.
ANDA 071229.................. Ibuprofen tablet, Do.
200 mg.
ANDA 071231.................. Ibuprofen tablet, Do.
400 mg.
ANDA 071232.................. Ibuprofen tablet, Do.
600 mg.
ANDA 071639.................. Ibuprofen tablet, Do.
200 mg.
ANDA 071644.................. Ibuprofen tablet, Do.
400 mg.
ANDA 072004.................. Ibuprofen tablet, Do.
800 mg.
ANDA 075659.................. AFEDITAB CR Watson
(nifedipine) Laboratories, Inc.
extended-release (an indirect,
tablet, 60 mg. wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.,) 400
Interpace Parkway,
Parsippany, NJ
07054.
ANDA 076024.................. Fluoxetine Fosun Pharma USA
hydrochloride (HCl) Inc., 104 Carnegie
tablet, equivalent Center, Suite 204,
to (EQ) 10 mg base. Princeton, NJ
08540.
ANDA 076191.................. Fexofenadine HCl Barr Laboratories,
tablet, 30 mg, 60 LLC. (an indirect,
mg, and 180 mg. wholly owned
subsidiary of Teva
Pharmaceuticals,
USA, Inc.,) 400
Interpace Parkway,
Parsippany, NJ
07054.
ANDA 076236.................. FEXOFENADINE Do.
HYDROCHLORIDE AND
PSEUDOEPHEDRINE
HYDROCHLORIDE
(Fexofenadine HCl;
pseudoephedrine
HCl) extended-
release tablet, 60
mg; 120 mg.
ANDA 076334.................. PREVIFEM (ethinyl Par Health USA LLC,
estradiol; U.S. Agent for PH
norgestimate) Health Ltd.
tablet, 0.035 mg;
0.25 mg.
ANDA 076335.................. TRI-PREVIFEM Do.
(ethinyl estradiol;
norgestimate)
tablet, 0.035 mg,
0.035 mg, 0.035 mg;
0.18 mg, 0.215 mg,
0.25 mg.
ANDA 076337.................. CYCLAFEM 1/35 Do.
(ethinyl estradiol;
norethindrone)
tablet, 0.035 mg; 1
mg.
ANDA 076338.................. CYCLAFEM 7/7/7 Do.
(ethinyl estradiol;
norethindrone)
tablet, 0.035 mg,
0.035 mg, 0.035 mg;
0.5 mg, 0.75 mg, 1
mg.
ANDA 076675.................. EMOQUETTE Do.
(desogestrel;
ethinyl estradiol)
tablet, 0.15 mg;
0.03 mg.
ANDA 076681.................. KIMIDESS Do.
(desogestrel;
ethinyl estradiol)
tablet, 0.15 mg, N/
A; 0.02 mg, 0.01 mg.
ANDA 077075.................. GILDESS 1.5/30 and Do.
GILDESS FE 1.5/30
(ethinyl estradiol;
norethindrone
acetate) tablet,
0.03 mg; 1.5 mg.
ANDA 077077.................. GILDESS 1/20 and Do.
GILDESS FE 1/20
(ethinyl estradiol;
norethindrone
acetate) tablet,
0.02 mg; 1 mg.
ANDA 077099.................. ORSYTHIA (ethinyl Do.
estradiol;
levonorgestrel)
tablet, 0.02 mg;
0.1 mg.
ANDA 077324.................. Levetiracetam Fosun Pharma USA
tablet, 250 mg, 500 Inc.
mg, 750 mg, and 1
gm.
ANDA 077502.................. MYZILRA (ethinyl Par Health USA LLC,
estradiol; U.S. Agent for PH
levonorgestrel) Health Ltd.
tablet, 0.03 mg,
0.04 mg, 0.03 mg;
0.05 mg, 0.075 mg,
0.125 mg.
ANDA 078376.................. GILDAGIA (ethinyl Do.
estradiol;
norethindrone)
tablet, 0.035 mg;
0.4 mg.
ANDA 078712.................. CIPROFLOXACIN Fosun Pharma USA
EXTENDED RELEASE Inc.
(ciprofloxacin;
ciprofloxacin HCl)
extended-release
tablet, 212.6 mg;
EQ 287.5 mg base.
ANDA 080326.................. Prednisolone tablet, Lachman Consultant
5 mg. Services, Inc.,
U.S. Agent for
Heather Drug
Company, 1600
Stewart Ave.,
Westbury, NY 11590
ANDA 080339.................. Prednisolone tablet, Fosun Pharma USA
5 mg. Inc.
ANDA 080832.................. Diphenhydramine HCl Do.
capsule, 25 mg and
50 mg.
ANDA 081249.................. ACETAMINOPHEN AND Do.
CODEINE PHOSPHATE
(acetaminophen;
codeine phosphate)
tablet, 300 mg; 60
mg.
[[Page 64654]]
ANDA 081250.................. ACETAMINOPHEN AND Do.
CODEINE PHOSPHATE
(acetaminophen;
codeine phosphate)
tablet, 300 mg; 30
mg.
ANDA 086398.................. BUTALBITAL, ASPIRIN Do.
AND CAFFEINE
(aspirin;
butalbital;
caffeine) tablet,
325 mg; 50 mg; 40
mg.
ANDA 090293.................. GILDESS 24 FE Par Health USA LLC,
(ethinyl estradiol; U.S. Agent for PH
norethindrone Health Ltd.
acetate) tablet,
0.02 mg; 1 mg.
ANDA 091520.................. Bupropion HCl Do.
extended-release
tablet, 150 mg.
ANDA 203413.................. CYCLAFEM 0.5/35 Do.
(ethinyl estradiol;
norethindrone)
tablet, 0.035 mg;
0.5 mg.
ANDA 203911.................. FLUDEOXYGLUCOSE F18 Nukemed, Inc. dba
(Fludeoxyglucose F- SpectronRx, 17490
18) injectable, 4- Dugdale Dr., South
500 millicurie/ Bend, IN 46635.
milliliter (mCi/mL).
ANDA 203912.................. Sodium fluoride F-18 Do.
injectable, 10-200
mCi/mL.
ANDA 204455.................. AMMONIA N 13 Do.
(ammonia N-13)
injectable, 30 mCi-
300 mCi/8 mL (3.75-
37.5 mCi/mL).
ANDA 205699.................. Bosentan tablet, Par Health USA LLC,
62.5 mg and 125 mg. U.S. Agent for PH
Health Limited, 9
Great Valley
Parkway, Malvern,
PA 19355.
------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of November
9, 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 November 9, 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. 2026-20762 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on October 9, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.