Determination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/Milliliter) and 250 Milligrams/250 Milliliters (1 Milligram/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA or the Agency) has determined that DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem hydrochloride (HCl)), 125 milligrams (mg)/125 milliliters (mL) (1 mg/ mL) and 250 mg/250 mL (1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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 diltiazem HCl, 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), if all other legal and regulatory requirements are met.
Abstract as published in the Federal Register.
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