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Zdrowie i gospodarka · 25.08.2014

Determination That SULAR (Nisoldipine) Extended-Release Tablets, 10 Milligrams, 20 Milligrams, 25.5 Milligrams, 30 Milligrams, and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) has determined that SULAR (nisoldipine) extended-release tablets, 10 milligrams (mg), 20 mg, 25.5 mg, 30 mg, and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 these drug products, and it will allow FDA to approve ANDAs for nisoldipine extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg, if all other legal and regulatory requirements are met.

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