The eRulemaking Program

06/03/2026 | Press release | Distributed by Public on 06/03/2026 06:47

Withdrawal of Approval of Drug Application: Elite Laboratories, Inc., et al.

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.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of July 6, 2026.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, [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 § 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 § 314.150(c) is without prejudice to refiling.

Table 1-ANDAs for Which Approval Is Withdrawn
Application No. Drug Applicant
ANDA 040227 Phentermine hydrochloride (HCl) capsule, 30 milligrams (mg) Elite Laboratories, Inc., 165/144/135 Ludlow Ave., Northvale, NJ 07647.
ANDA 040460 Phentermine HCl capsule, 15 mg Do.
ANDA 065025 Cyclosporine solution, 100 mg/milliliters (mL) AbbVie Inc., 1 N Waukegan Rd., North Chicago, IL 60064.
ANDA 075180 Ranitidine HCl tablet, Equivalent to (EQ) 150 mg and EQ 300 mg Par Health USA LLC, U.S. Agent for PH Health Limited, 300 Tice Blvd., Suite 230, Woodcliff Lake, NJ 07677.
ANDA 076434 PAROEX (chlorhexidine gluconate) solution, 0.12% Sunstar Americas, Inc., 301 E Central Rd., Schaumburg, IL 60195.
ANDA 090734 OXYCODONE AND ACETAMINOPHEN (acetaminophen; oxycodone HCl) tablet, 325 mg; 7.5 mg and 325 mg; 10 mg Par Health USA LLC, U.S. Agent for PH Health Limited, 9 Great Valley Parkway, Malvern, PA 19355.
ANDA 204960 Cisatracurium besylate injectable, EQ 2 mg base/mL, CISATRACURIUM BESYLATE PRESERVATIVE FREE (cisatracurium besylate) injectable EQ 2 mg base/mL and EQ 10 mg base/mL eVenus Pharmaceutical Lab Inc., U.S. Agent for Jiangsu Hengrui Pharmaceuticals Co., Ltd., 506 Carnegie Center, Suite 102, Princeton, NJ 08540.
ANDA 206159 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE 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 Par Health USA LLC, U.S. Agent for PH Health Limited.
ANDA 207366 Ribavirin solution, 6 grams/vial Navinta LLC, 1499 Lower Ferry Rd., Ewing, NJ 08618.
ANDA 210653 Clomipramine HCl capsule, 25 mg, 50 mg, and 75 mg PTS Consulting, LLC, U.S. Agent for TP ANDA HOLDINGS, LLC., 6739 Valhalla Ct., Shawnee, KS 66217.
ANDA 210948 Albuterol sulfate tablet, EQ 2 mg base and EQ 4 mg base Makro Technologies Inc., (Makrocare) U.S. Agent for Aizant Drug Research Solutions Private Limited, 116 Village Blvd., Suite # 200, Princeton, NJ 08540.
ANDA 211538 Vasopressin solution, 20 units/mL Eagle Pharmaceuticals, Inc., 50 Tice Blvd., Suite 315, Woodcliff Lake, NJ 07677.
ANDA 212106 Entecavir tablet, 0.5 mg and 1 mg CMC GMP LLC, U.S. Agent for Pharmadax Inc., 9805 NE 116th St. PMB #A255, Kirkland, WA 98034.
ANDA 212957 Fosaprepitant dimeglumine powder, EQ 150 mg base/vial Navinta LLC.
ANDA 214423 Venlafaxine HCl extended-release tablet, EQ 75 mg base and EQ 150 mg base CMC GMP LLC, U.S. Agent for Pharmadax Inc.
ANDA 218638 Nicardipine HCl capsule, 20 mg and 30 mg Navinta LLC.

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
The eRulemaking Program published this content on June 03, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on June 03, 2026 at 12:47 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]