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Zdrowie i gospodarka · 30.05.2025

Determination That COREG CR (Carvedilol Phosphate) Extended-Release Capsules, 10 Milligrams, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA, Agency, or we) has determined that COREG CR (carvedilol phosphate) extended-release capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

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