FDA Approves Labeling for Granisetron Hydrochloride Tablet (ANDA078080)

The U.S. Food and Drug Administration has approved several labeling submissions for ANDA078080, the abbreviated new drug application for granisetron hydrochloride oral tablets marketed by Teva Pharmaceuticals. The product is an oral tablet containing an equivalent of 1 mg granisetron hydrochloride base. Its marketing status is recorded as discontinued. Submission history includes an original approval (submission 1) dated 31 Dec 2007, a labeling supplement approved on 28 Jan 2010 (submission 1), another labeling supplement approved on 11 Apr 2012 (submission 4), a labeling supplement and accompanying FDA letter approved in September 2014 (submission 5), and the most recent labeling approval on 12 Aug 2022 (submission 8). Relevant label PDFs and FDA correspondence are available through the FDA’s accessdata website. These approvals reflect ongoing regulatory updates to the product’s labeling despite its discontinued marketing status.