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Business · 17/02/2021Updated: 10/17/2026 · 1 min read

FDA Clears Nimodipine for Potential Approval via Abbreviated New Drug Applications

The FDA has determined that NYMALIZE (nimodipine) oral solution, 3 mg/mL, was not withdrawn from sale due to safety or effectiveness concerns, paving the way for potential approval of abbreviated new drug applications (ANDAs) for this product.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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