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Zdrowie i gospodarka · 5.04.2024

Determination That GLUCOTROL (Glipizide) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The Food and Drug Administration (FDA or Agency) has determined that GLUCOTROL (glipizide) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.

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