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Determination That ROWASA (mesalamine) Rectal Suppositories, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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(FDA) is announcing its determination that ROWASA (mesalamine) Rectal Suppositories, 500 milligrams (mg) was not withdrawn from sale for reasons of safety or effectiveness.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.