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İş dünyası · 22.05.19981 dk okuma

Determination That Cimetidine 100 mg Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Özet

The Food and Drug Administration (FDA) has determined that cimetidine 100 milligram (mg) tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA's) for drugs that refer to cimetidine 100 mg tablets.

Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →