FDA Approves Ethosuximide Oral Syrup (ANDA 081306)

The U.S. Food and Drug Administration has granted approval for an oral syrup formulation of ethosuximide, listed under brand name ETHOSUXIMIDE and application number ANDA 081306. The product is recorded with a marketing status of "Discontinued". Product details include an oral route, syrup dosage form, product number 001, and a single active ingredient: ethosuximide at a strength of 250 mg per 5 ml. The approval package references a series of supplemental (SUPPL) submissions that were all approved (status "AP"). These submissions cover manufacturing (CMC) and labeling activities and span submission numbers 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 14, and 17, with approval dates ranging from 1994‑01‑21 to 2010‑06‑29. Manufacturing (CMC) submissions were approved on multiple dates (e.g., 1994‑01‑21, 1995‑06‑31, 1998‑10‑29, 1999‑03‑23, 1999‑09‑20, 2001‑02‑26, 2001‑10‑31, 2002‑01‑23) and labeling submissions were approved on 2002‑04‑08, 2002‑09‑27, and 2010‑06‑29.