The Food and Drug Administration (FDA or Agency) has determined that PREVACID IV (lansoprazole) intravenous injection, 30 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for lansoprazole intravenous injection, 30 mg/vial, if all other legal and regulatory requirements are met.
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Determination That PREVACID IV (Lansoprazole) Intravenous Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that PREVACID IV (lansoprazole) intravenous injection, 30 milligrams (mg)/vial, was not withdrawn from sale for r...
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81 FR 62143
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“Determination That PREVACID IV (Lansoprazole) Intravenous Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” thefederalregister.org (September 8, 2016), https://thefederalregister.org/documents/2016-21551/determination-that-prevacid-iv-lansoprazole-intravenous-injection-30-milligrams-vial-was-not-withdrawn-from-sale-for-rea.