federal_register: 2011-32367

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2011-32367 Determination that Bretylium Tosylate Injection, 50 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that Bretylium Tosylate injection, 50 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Bretylium Tosylate injection, 50 mg/mL, if all other legal and regulatory requirements are met. 2011-12-19 2011 12 https://www.federalregister.gov/documents/2011/12/19/2011-32367/determination-that-bretylium-tosylate-injection-50-milligramsmilliliter-was-not-withdrawn-from-sale https://www.govinfo.gov/content/pkg/FR-2011-12-19/pdf/2011-32367.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that Bretylium Tosylate injection, 50 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated...

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