Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Abstract as published in the Federal Register.
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