Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2026-04799 · FDA-2026-N-1226

Summary

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 15 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of April 13, 2026.

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 Table 1—ANDAs for Which Approval Is Withdrawn Application No. Drug Applicant ANDA 074316 Cimetidine, tablet, 800 milligrams (mg) Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Parkway, Building A, Parsippany, NJ 07054. ANDA 074349 Cimetidine, tablet, 200 mg, 300 mg, and 400 mg Do. ANDA 074424 Cimetidine, tablet, 200 mg, 300 mg, 400 mg, and 800 mg IVAX Pharmaceuticals, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Parkway, Building A, Parsippany, NJ 07054. ANDA 074803 Fluoxetine hydrochloride (HCl), capsule, Equivalent to (EQ) 10 mg base and EQ 20 mg base Barr Laboratories LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Parkway, Building A, Parsippany, NJ 07054. ANDA 075062 Famotidine, tablet, 20 mg and 40 mg Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.). ANDA 075238 Sotalol HCl, tablet, 80 mg, 120 mg, 160 mg, and 240 mg Do. ANDA 075297 Paclitaxel, injectable, 6 mg/milliliters (mL) Teva Pharmaceuticals USA, Inc., 400 Interpace Parkway, Building A, Parsippany, NJ 07054. ANDA 075345 Cimetidine, tablet, 200 mg IVAX Pharmaceuticals, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.). ANDA 075353 Doxazosin mesylate, tablet, EQ 1 mg base, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base Teva Pharmaceuticals USA, Inc. ANDA 075425 Cimetidine, tablet, 200 mg Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.). ANDA 075426 Doxazosin mesylate, tablet, EQ 1 mg base, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base Do. ANDA 075485 Gabapentin, capsule, 100 mg, 300 mg, and 400 mg Do. ANDA 075574 Doxazosin mesylate, tablet, EQ 1 mg base, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base Actavis Elizabeth LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Parkway, Building A, Parsippany, NJ 07054. ANDA 075632 Bisoprolol fumarate and hydrochlorothiazide, tablet, 2.5 mg; 6.25 mg, 5 mg; 6.25 mg, and 10 mg; 6.25 mg IVAX Pharmaceuticals, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.). ANDA 076028 Vinorelbine tartrate, injectable, EQ 10 mg base/mL Teva Pharmaceuticals USA, Inc. Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, are hereby withdrawn as of April 13, 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 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 April 13, 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. 2026-04799 Filed 3-11-26; 8:45 am]