Determination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/Milliliter, Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness

Resumo

The Food and Drug Administration (FDA or Agency) has determined that ZANTAC (ranitidine hydrochloride (HCl)) injection, equivalent to (EQ) 25 milligram (mg) base/milliliter (mL), has not been withdrawn from sale for reasons of safety or effectiveness to the extent that the drug can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. 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 it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements, including satisfying any applicable acceptable intake limit for nitrosamine impurities.