Regulatory UpdatesAug 30, 2026•1 min read

FDA Approves ANDA078671 for NABUMETONE Oral Tablets

By the PharmaCountry team

FDA granted approval for ANDA078671 covering prescription NABUMETONE tablets (500 mg and 750 mg) from sponsor Invagen Pharms, manufactured by Exelan Pharmaceuticals and Cipla USA.

The U.S. Food and Drug Administration has approved application ANDA078671 for the generic drug NABUMETONE. The approval covers oral tablet products containing 500 mg and 750 mg of NABUMETONE, marketed as prescription drugs. Two product entries are listed: product number 001 (500 mg) and product number 002 (750 mg). The sponsor is Invagen Pharms. Manufacturing responsibilities are assigned to Exelan Pharmaceuticals Inc. and Cipla USA Inc. The products are identified by multiple NDC codes, including 76282-257-01, 76282-257-05, 76282-258-01, 76282-258-05, 69097-965-07, and 69097-966-12. The approval timeline includes an original submission (submission 1) approved on March 7 2008, and subsequent labeling supplements approved on May 9 2016, April 28 2021, and November 21 2024. NABUMETONE is classified as a non‑steroidal anti‑inflammatory drug (NSAID) and a cyclooxygenase inhibitor.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#NABUMETONE #ANDA078671 #FDA approval #oral tablets #NSAID #pharmaceutical regulation