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Zdrowie i gospodarka · 14/07/2016

Determination That PARAFON FORTE DSC (Chlorzoxazone) Tablets, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that PARAFON FORTE DSC (chlorzoxazone) tablets, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and this determination will allow FDA to continue to approve ANDAs for chlorzoxane tablets, 500 mg, if all other legal and regulatory requirements are met.

Source: Federal Register — Food and Drug AdministrationOpen original release →