Regulatory UpdatesSep 12, 2026•1 min read

FDA Approves ANDA077545 for Ondansetron Hydrochloride Tablets

By the PharmaCountry team

FDA approved application ANDA077545 from Hikma International Pharmaceuticals for discontinued oral ondansetron tablets (4 mg, 8 mg, 24 mg) with multiple labeling supplements approved.

The U.S. Food and Drug Administration has approved ANDA077545, submitted by Hikma International Pharmaceuticals, for ondansetron hydrochloride tablets. The application covers three oral tablet products (product numbers 001, 002, 003) with strengths equivalent to 4 mg, 8 mg, and 24 mg base, respectively. All three are listed as discontinued. The original submission (submission 1) received approval on September 6 2007. Since then, a series of labeling supplements (submissions 2,3,4,7,8,11,12,13,14) have been approved, with the most recent approvals dated May 15 2023. No reference drug status or reference standard is indicated for these products.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Ondansetron #generic #ANDA #FDA #labeling #pharmaceuticals