FDA Grants Approval for Ethosuximide 250 mg Oral Capsules (ANDA 211928)

The U.S. Food and Drug Administration has granted approval for application ANDA 211928, covering ethosuximide oral capsules. The product is a 250 mg tablet intended for oral administration and is classified as a prescription human drug. The approved product is manufactured by Strides Pharma Science Limited and marketed under the sponsor name ONESOURCE. It carries the National Drug Code 64380‑878‑06 and is listed under the generic and brand name ETHOSUXIMIDE. The drug is categorized as an anti‑epileptic agent with pharmacologic activity aimed at decreasing disorganized electrical activity in the central nervous system. The approval timeline includes an original submission (ORIG) that received an “AP” status on 19 February 2019, followed by two labeling supplement submissions (SUPPL) that were approved on 25 August 2022. All submissions were reviewed under standard priority.