Digoxin products for oral use; revocation of conditions for marketing. Final rule.
The Food and Drug Administration (FDA) is revoking the regulation establishing conditions for marketing digoxin products for oral use. This regulation is no longer necessary because the products, which are new drugs, can be regulated under the approval process for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) as set forth in the Federal Food, Drug, and Cosmetic Act (the act).
D000284:Administration, Oral; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage; D004077:Digoxin / Q000008:administration & dosage; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D000889:Anti-Arrhythmia Agents; D004077:Digoxin