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Regulatory Updates | Pharmacountry Insights

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Regulatory Updates

FDA, EMA, TGA and global regulatory developments

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Daily News Market Analysis Research & Reports Regulatory Updates

Regulatory Updates

Sep 18, 2026•3 min read

FDA Approves ANDA078127 for Ondansetron Oral Solution

The FDA has approved application ANDA078127 for an oral ondansetron solution (4 mg/5 mL) marketed by PAI Holdings, LLC dba PAI Pharma.