Actualités réglementaires12 sept. 2026•1 min de lecture

FDA Approves PROCHLORPERAZINE EDISYLATE Injection (ANDA212257)

Par l'équipe PharmaCountry

The FDA has approved the ANDA212257 application for PROCHLORPERAZINE EDISYLATE injectable, manufactured by Somerset Therapeutics, for intramuscular and intravenous use.

The U.S. Food and Drug Administration has granted approval for the Abbreviated New Drug Application (ANDA) number 212257 for PROCHLORPERAZINE EDISYLATE. The product, marketed by Somerset Therapeutics, LLC, is an injectable formulation available for intramuscular and intravenous administration. The original submission received an approved status on September 13, 2024, and a labeling supplement was approved on June 1, 2026. The drug is classified as a prescription human medication, with the generic and brand names both listed as PROCHLORPERAZINE EDISYLATE. It is supplied under NDC codes 70069-371-01 and 70069-371-25.

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

Sujets :#Prochlorperazine #ANDA #FDA #injection #Somerset Therapeutics