The Food and Drug Administration (FDA or Agency) has determined that NIZORAL (ketoconazole) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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 NIZORAL, and it will allow FDA to continue to approve ANDAs that reference NIZORAL as long as they meet relevant legal and regulatory requirements.
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Determination That NIZORAL (Ketoconazole) Tablets, 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that NIZORAL (ketoconazole) tablets, 200 milligrams (mg), were not withdrawn from sale for reasons of safety or e...
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82 FR 41624
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“Determination That NIZORAL (Ketoconazole) Tablets, 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” thefederalregister.org (September 1, 2017), https://thefederalregister.org/documents/2017-18548/determination-that-nizoral-ketoconazole-tablets-200-milligrams-were-not-withdrawn-from-sale-for-reasons-of-safety-or-eff.