[Federal Register Volume 90, Number 183 (Wednesday, September 24, 2025)]
[Notices]
[Pages 45942-45944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-18453]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA-2025-N-3346]
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72
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 72 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of October 23, 2025.
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: 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.
[[Page 45943]]
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Table 1--ANDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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ANDA 040228............... Phentermine Elite Laboratories,
Hydrochloride (HCl) Inc., 165/144/135
capsule, 37.5 Ludlow Ave.,
milligrams (mg). Northvale, NJ 07647.
ANDA 040538............... Prednisone tablet, Hikma Pharmaceuticals
2.5 mg. USA Inc., U.S. Agent
for Hikma
Pharmaceuticals LLC,
1809 Wilson Rd.,
Columbus, OH 43228.
ANDA 040890............... Prednisone tablet, 1 Do.
mg.
ANDA 063000............... Polymyxin B Sulfate Adrastea Pharma LLC,
injectable, 1008 S Main St.,
Equivalent to (EQ) Suite 225,
500,000 units base/ Georgetown, TX
vial. 78626.
ANDA 065175............... Nystatin powder, Do.
100,000 units/gram
(gm).
ANDA 065177............... Colistimethate Sodium Nexus
injectable, EQ 150 Pharmaceuticals,
mg base/vial. LLC, 400
Knightsbridge
Parkway,
Lincolnshire, IL
60069.
ANDA 065455............... Vancomycin HCl Hospira, Inc., 275
injectable, EQ 10 gm North Field Dr.,
base/vial. Building H1-3S, Lake
Forest, IL 60045.
ANDA 065511............... Azithromycin Do.
injectable, EQ 500
mg base/vial.
ANDA 070631............... Valproic Acid Upsher-Smith
capsule, 250 mg. Laboratories, LLC,
6701 Evenstad Dr.,
Maple Grove, MN
55369.
ANDA 071425............... DESOWEN (desonide) Galderma
ointment, 0.05%. Laboratories, L.P.,
2001 Ross Ave.,
Suite 1600, Dallas,
TX 75201.
ANDA 072354............... DESOWEN (desonide) Do.
ointment, 0.05%.
ANDA 072786............... Fentanyl Citrate Hospira, Inc.
injectable, EQ 0.05
mg base/milliliter
(mL).
ANDA 073045............... Albuterol aerosol, Mylan Pharmaceuticals
metered, 0.9 mg/ ULC (formerly
inhalation. Genpharm Inc.), 781
Chestnut Ridge Rd.,
Morgantown, WV
26505.
ANDA 074332............... Bumetanide Hospira, Inc.
injectable, 0.25 mg/
mL.
ANDA 074776............... Timolol Maleate Bausch & Lomb Inc.,
solution, EQ 0.5% 400 Somerset
base. Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 074778............... Timolol Maleate Do.
solution, EQ 0.25%
base.
ANDA 074912............... Selegiline HCl Stason
tablet, 5 mg. Pharmaceuticals,
Inc., U.S. Agent for
Kenton Chemicals and
Pharmaceuticals
Corp., 11 Morgan,
Irvine, CA 92618.
ANDA 074941............... Diltiazem HCl Hospira, Inc.
injectable, 5 mg/mL.
ANDA 074993............... Ketorolac Do.
Tromethamine
injectable, 30 mg/
mL, and 15 mg/mL.
ANDA 075505............... Loratadine syrup, 1 Teva Pharmaceuticals
mg/mL. USA, Inc., 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 075940............... Dacarbazine Hospira, Inc.
injectable, 200 mg/
vial.
ANDA 075962............... Tramadol HCl tablet, Watson Laboratories,
50 mg. Inc. (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Parkway, Building A,
Parsippany, NJ
07054.
ANDA 076715............... Modafinil tablets, Do.
100 mg, and 200 mg.
ANDA 076774............... Haloperidol Syneos Health, LLC,
injectable, EQ 5 mg U.S. Agent for Gland
base/mL. Pharma Limited, 1030
Sync St.,
Morrisville, NC
27560.
ANDA 078024............... Ciprofloxacin in Baxter Healthcare
Dextrose, Corp., One Baxter
injectable, 5% in Parkway, Deerfield,
plastic container, IL 60015.
200 mg/100 mL, and
400 mg/200 mL.
ANDA 078030............... Stavudine for Cipla USA, Inc., U.S.
solution, 1 mg/mL. Agent for Cipla
Limited, 10
Independence Blvd.,
Suite 300, Warren,
NJ 07059.
ANDA 078062............... Ciprofloxacin Baxter Healthcare
injectable, 200 mg/ Corp.
20 mL (10 mg/mL),
and 400 mg/40mL (10
mg/mL).
ANDA 078084............... Metronidazole in Do.
plastic container,
injectable, 500 mg/
100 mL.
ANDA 078095............... Zaleplon capsules, 5 Upsher-Smith
mg, and 10 mg. Laboratories, LLC.
ANDA 078213............... Propranolol HCl NorthStar Rx LLC,
tablets, 10 mg, 20 U.S. Agent for
mg, 40 mg, 60 mg, NorthStar Healthcare
and 80 mg. Holdings Limited,
4835 Crumpler Rd.,
Suite A, Memphis, TN
38141.
ANDA 078253............... Allopurinol tablets, Do.
100 mg, and 300 mg.
ANDA 079211............... Ranitidine HCl syrup, Morton Grove
EQ 15 mg base/mL. Pharmaceuticals Inc./
Wockhardt USA LLC,
U.S. Agent for
Wockhardt Limited,
6451 Main St.,
Morton Grove, IL
60053.
ANDA 079212............... Ranitidine HCl syrup, Do.
EQ 15 mg base/mL.
ANDA 084399............... Phendimetrazine Upsher-Smith
Tartrate tablet, 35 Laboratories, LLC.
mg.
ANDA 088465............... Prednisone tablet, 50 Hikma Pharmaceuticals
mg. USA Inc., U.S. Agent
for Hikma
Pharmaceuticals LLC.
ANDA 089804............... Fluphenazine HCl Prasco, LLC dba
tablets, 1 mg, 2.5 Prasco Laboratories,
mg, 5 mg, and 10 mg. 6125 Commerce Ct.,
Mason, OH 45040.
ANDA 090071............... Venlafaxine HCl Bausch Health US LLC,
extended-release 400 Somerset
capsules, EQ 37.5 mg Corporate Blvd.,
base, EQ 75 mg base, Bridgewater, NJ
and EQ 150 mg base. 08807.
ANDA 090075............... Epirubicin HCl Hisun Pharmaceuticals
injectable, 50 mg/25 USA, Inc., U.S.
mL (2 mg/mL), and Agent for Hisun
200 mg/100 mL (2 mg/ Pharmaceutical
mL). (Hangzhou) Co.,
Ltd., 200 Crossing
Blvd., 2nd floor,
Bridgewater, NJ
08807.
ANDA 090125............... Nicardipine HCl Navinta LLC, 1499
injectable, 25 mg/10 Lower Ferry Rd.,
mL (2.5 mg/mL). Ewing, NJ 08618.
ANDA 090811............... Bivalirudin Hospira, Inc.
injectable, 250 mg/
vial.
ANDA 091095............... Nitrofurantoin Actavis Laboratories
capsules, 25 mg, 50 FL, Inc., an
mg, and 100 mg. indirect, wholly
owned subsidiary of
Teva Pharmaceuticals
USA, Inc., 400
Interpace Parkway,
Building A,
Parsippany, NJ
07054.
ANDA 091152............... Benztropine Mesylate Luitpold
injectable, 1 mg/mL. Pharmaceuticals,
Inc., One Luitpold
Dr., P.O. Box 9001,
Shirley, NY 11967.
ANDA 091397............... Levofloxacin Baxter Healthcare
injectable, EQ 250 Corp.
mg/50 mL (EQ 5 mg/
mL), EQ 750 mg/150
mL (EQ 5 mg/mL), and
EQ 500 mg/100 mL (EQ
5 mg/mL).
ANDA 091596............... Tranexamic Acid Fresenius Kabi USA,
injectable, 100 mg/ LLC, Three Corporate
mL. Dr., Lake Zurich, IL
60047.
ANDA 091667............... Misoprostol tablets, Novel Laboratories
0.1 mg, and 0.2 mg. Inc., 400 Campus
Dr., Somerset, NJ
08873.
ANDA 091671............... Hydrocodone Neos Therapeutics,
Polistirex and LP, 2940 N Highway
Chlorpheniramine 360, Suite 400,
Polistirex extended- Grand Prairie, TX
release suspension, 75050.
EQ 8 mg maleate/5
mL; EQ 10 mg
bitartrate/5 mL.
ANDA 201634............... Donepezil HCl Indicus Pharma LLC,
tablets, 5 mg, and 2530 Meridian
10 mg. Parkway, Suite 300,
Durham, NC 27713.
ANDA 203106............... Potassium Chloride Upsher-Smith
extended-release Laboratories, LLC.
capsules, 8
milliequivalent
(mEq) and, 10 mEq.
ANDA 203110............... Hydralazine HCl Adrastea Pharma LLC.
injectable, 20 mg/mL.
[[Page 45944]]
ANDA 203665............... Fludeoxyglucose F18 SOFIE Co. dba SOFIE,
injectable, 20-500 21000 Atlantic
millicurie (mCi)/mL. Blvd., Suite 730,
Dulles, VA 20166.
ANDA 204403............... Rivastigmine extended- Alvogen, Inc., 44
release film, 4.6 mg/ Whippany Rd., Suite
24 hours (hr), 9.5 300, Morristown, NJ
mg/24 hr, and 13.3 07960.
mg/24 hr.
ANDA 204530............... Sodium Fluoride F18 B&H Consulting
injectable, 10-200 Services, Inc., U.S.
mCi/mL. Agent for Hot Shots
NM, LLC, 50 Division
St., Suite 206,
Somerville, NJ
08876.
ANDA 204541............... Sodium Fluoride F18 Essential Isotopes
injectable, 10-200 LLC, 1513 Research
mCi/mL. Park Dr., Columbia,
MO 65211.
ANDA 204667............... Ammonia N 13 SOFIE Co. dba SOFIE.
injectable, 18.8 mCi-
188 mCi/5 mL (3.75-
37.5 mCi/mL).
ANDA 204860............... Prochlorperazine Nexus
Edisylate Pharmaceuticals,
injectable, EQ 5 mg LLC.
base/mL.
ANDA 205901............... Telmisartan tablets, Hetero USA, Inc.,
20 mg, 40 mg, and 80 U.S. Agent for
mg. Hetero Labs Ltd.,
Unit V, 1035
Centennial Ave.,
Piscataway, NJ
08854.
ANDA 206071............... Methocarbamol Navinta LLC.
solution, 1 gram
(gm)/10 mL (100 mg/
mL).
ANDA 206468............... Dicyclomine HCI Nexus
injectable, 10 mg/mL. Pharmaceuticals,
LLC.
ANDA 206561............... Indomethacin Sodium Navinta LLC.
injectable, EQ 1 mg
base/vial.
ANDA 206681............... Oxacillin Sodium Piramal Critical
injectable, EQ 1 gm Care, Inc., 3950
base/vial, and EQ 2 Schelden Circle,
gm base/vial. Bethlehem, PA 18017.
ANDA 206724............... Budesonide delayed- Syneos Health, LLC,
release capsule, 3 U.S. Agent for Natco
mg. Pharma Limited, 1030
Sync St.,
Morrisville, NC
27560.
ANDA 206760............... Oxacillin Sodium Piramal Critical
injectable, EQ 10 gm Care, Inc.
base/vial.
ANDA 208679............... Fludeoxyglucose F 18 Memorial Sloan
injectable, 20-300 Kettering Cancer
mCi/mL. Center, 1275 York
Ave., New York, NY
10065.
ANDA 208878............... Midazolam HCI Fresenius Kabi USA,
injectable, EQ 5 mg LLC.
base/mL.
ANDA 210356............... Haloperidol Do.
injectable, EQ 5 mg
base/mL.
ANDA-210774............... Acyclovir ointment, Apotex Corp., U.S.
5%. Agent for Apotex
Inc., 2400 North
Commerce Pkwy.,
Suite 400, Weston,
FL 33326.
ANDA 211794............... Acyclovir ointment, Cipla USA, Inc., U.S.
5%. Agent for Cipla
Limited.
ANDA 212775............... Azelastine HCl spray, Aurobindo Pharma USA,
metered, 0.2055 mg/ Inc., U.S. Agent for
spray. Aurobindo Pharma
Ltd., 279 Princeton-
Hightstown Rd., East
Windsor, NJ 08520.
ANDA 213247............... Metformin HCI Elity, LLC, U.S.
extended-release Agent for TWi
tablets, 500 mg, and Pharmaceuticals,
1 gm. Inc., 175 SW 166th
Ave., Pembroke
Pines, FL 33027.
ANDA 213394............... Metformin HCI PHL US Pharma LLC,
extended-release U.S. Agent for
tablets, 500 mg, and Utopic
1 gm. Pharmaceuticals
Inc., 3396 Kipling
St., Palo Alto, CA
94306.
ANDA 213823............... Bortezomib Baxter Healthcare
injectable, 3.5 mg/ Corp.
vial.
ANDA 214436............... Pemetrexed Disodium Do.
powder, EQ 100 mg
base/vial, and EQ
500 mg base/vial.
ANDA 218354............... Edaravone solution, Long Grove
30 mg/100 mL (0.3 mg/ Pharmaceuticals LLC,
mL). 9450 W Bryn Mawr
Ave., Suite 200,
Rosemont, IL 60018.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of October
23, 2025. 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 new drug application or
ANDA 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 October 23, 2025 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. 2025-18453 Filed 9-23-25; 8:45 am]
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