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2026-07-09 · Notice · Federal Register document 2026-13820

Determination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Official abstract: The Food and Drug Administration (FDA, Agency, or we) has determined that TOVALT ODT (zolpidem tartrate) orally disintegrating tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zolpidem tartrate, orally disintegrating tablets, 5 mg and 10 mg, if all other legal and regulatory requirements are met.

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