Determination That ZOFRAN ODT (Ondansetron) Orally Disintegrating Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA or the Agency) has determined that ZOFRAN ODT (ondansetron) orally disintegrating tablets, 4 milligrams (mg) and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Abstract as published in the Federal Register.
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