Determination That DITROPAN XL (Oxybutynin Chloride) Extended Release Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

SUMMARY

The Food and Drug Administration (FDA or Agency) has determined that DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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 DITROPAN XL (oxybutynin chloride) Extended Release Tablets, 15 mg, if all other legal and regulatory requirements are met.


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