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Zdrowie i gospodarka · 28.03.2000

Determination That Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 Milligrams/325 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that hydrocodone bitartrate and acetaminophen tablets USP, 5 milligrams (mg)/325 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA's) for this drug product.

Source: Federal Register — Food and Drug AdministrationOpen original release →