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Zdrowie i gospodarka · 24.05.2001

Determination That ROWASA (mesalamine) Rectal Suppositories, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA) is announcing its determination that ROWASA (mesalamine) Rectal Suppositories, 500 milligrams (mg) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mesalamine rectal suppositories, 500 mg.

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