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Zdrowie i gospodarka · 13/02/2012

Determination That KAPVAY (Clonidine Hydrochloride) Extended-Release Tablets, 0.2 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that KAPVAY (clonidine hydrochloride) Extended-Release Tablets, 0.2 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for clonidine hydrochloride extended- release tablets, 0.2 mg, if all other requirements are met.

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