Determination That Potassium Citrate, 10 Milliequivalents/Packet and 20 Milliequivalents/Packet, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

The Food and Drug Administration (FDA) has determined that Potassium Citrate, 10 milliequivalents/packet (mEq/packet) and 20 mEq/ packet, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Potassium Citrate, 10 mEq/packet and 20 mEq/packet, if all other legal and regulatory requirements are met.