Regulatory UpdatesSep 11, 2026•1 min read

FDA Grants ANDA Approval for PHARMASCIENCE INC (ANDA205757)

By the PharmaCountry team

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.

Compiled by the PharmaCountry team · Source: FDA.gov

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