4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2024-N-2803] Sandoz Inc., et al.; Withdrawal of Approval of 20 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 20 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 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, Martha.Nguyen@fda.hhs.gov. 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. Application No. ANDA 040118 ANDA 040291 Table 1.--ANDAs for Which Approval Is Withdrawn Drug Applicant Carisoprodol, Aspirin and Codeine Phosphate Tablets, 325 milligrams (mg), 200 mg, and 16 mg Fluorouracil Injection, 50 mg/milliliters (mL) Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540 Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL Application No. Drug ANDA 071849 Morphine Sulfate Injectable, 0.5 mg/mL ANDA 074133 Metoprolol Tartrate Injectable, 1 mg/mL Nitrofurantoin (Monohydrate/Macrocrystals) Capsules, 75 mg, and 25 mg Ondansetron Hydrochloride (HCl) Preservative Free Injection, Equivalent to (EQ) 2 mg base/mL Ondansetron HCl Injectable, EQ 2 mg base/mL Ondansetron HCl Injection, EQ 2 mg base/mL Dexamethasone Sodium Phosphate Injection, EQ 4 mg phosphate/mL Mepivacaine HCl and Levonordefrin Injection, 0.05 mg/mL; 2% ANDA 076648 ANDA 077387 ANDA 077582 ANDA 079039 ANDA 087440 ANDA 088388 ANDA 090578 ANDA 090579 ANDA 090723 ANDA 207266 ANDA 207794 Ampicillin and Sulbactam For Injection, EQ 10 grams(g) base/vial and EQ 5 grams (g) base/vial Ampicillin and Sulbactam For Injection, EQ 1 g base/vial, EQ 500 mg base/vial, EQ 2 g base/vial, and EQ 1 g base/vial Duloxetine HCl Capsules, Delayed-Release Pellets, EQ 20 mg base, EQ 30 mg base, and EQ 60 mg base Bupivacaine HCl Injectable, 0.75% Busulfan Injection, 6 mg/mL ANDA 209068 Chlorthalidone Tablets, 25 mg and 50 mg ANDA 212223 Captopril Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg Applicant Hospira, Inc., 275 North Field Dr., Building H1-3S, Lake Forest, IL 60045 Do. Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520 American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967 Do. Do. Do. ICON Clinical Research, LLC, U.S. Agent for Deproco, Inc., 4130 ParkLake Ave., Suite 400, Raleigh, NC 27612 EAS Consulting Group, LLC, U.S. Agent for Astral SteriTech Pvt. Ltd., 1700 Diagonal Rd., # 750, Alexandria, VA 22314 Do. Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., 150 Motor Pkwy., Suite 401, 4th Floor, Rm. 430, Hauppauge, NY 11788 Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015 Nexus Pharmaceuticals, Inc., 400 Knightsbridge Pkwy., Lincolnshire, IL 60069 Elity LLC, U.S. Agent for Sunny Pharmtech Inc., 175 SW 166th Ave., Pembroke Pines, FL 33027 Pharmobedient Consulting, LLC, U.S. Agent for Seton Pharmaceuticals, LLC, 642 North East 3rd Ave., Application No. ANDA 212287 ANDA 212721 ANDA 213552 Drug Piperacillin and Tazobactam For Injection, EQ 2 g base/vial, EQ 250 mg base/vial, EQ 3 g base/vial, EQ 375 mg base/vial, EQ 4 g base/vial, and EQ 500 mg base/vial Cefepime HCl For Injection, EQ 1 g base/vial and EQ 2 g base/vial Succinylcholine Chloride Injection, 20 mg/mL Applicant Fort Lauderdale, FL 33304 EAS Consulting Group, LLC Do. Nexus Pharmaceuticals, Inc. Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER] 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. Dated: June 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-13660 Filed: 6/20/2024 8:45 am; Publication Date: 6/21/2024]