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Zdrowie i gospodarka · 31/05/2016

FDA Clears Levothyroxine Sodium Tablets for Approval via Abbreviated New Drug Applications

The US Food and Drug Administration (FDA) has made a determination that certain Levothyroxine Sodium tablets, including those in various milligram strengths, were not withdrawn from sale due to safety or effectiveness concerns, paving the way for the approval of abbreviated new drug applications (ANDAs) for these products if they meet all applicable legal and regulatory requirements.

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