Actualités réglementaires11 sept. 2026•1 min de lecture

FDA Grants ANDA Approval for PHARMASCIENCE INC (ANDA205757)

Par l'équipe PharmaCountry

The FDA issued a standard review tentative approval (TA) for ANDA205757 submitted by Pharmascience Inc., status dated Feb 15, 2019.

The U.S. Food and Drug Administration (FDA) has processed Abbreviated New Drug Application (ANDA) number ANDA205757 submitted by Pharmascience Inc. The submission was classified under a standard review priority and recorded a status of "TA" (tentative approval) on February 15, 2019. No additional details about the product or approval conditions were provided in the filing information. This entry reflects the regulatory milestone for the generic drug application as reported by the FDA's drug approval records.

Compilé par l'équipe PharmaCountry · Source : FDA.gov

Sujets :#FDA #ANDA #Regulatory Approval #Pharmascience #generic drugs