FDA Approval Activities for this Drug…

SYNERCID I.V. (quinupristin and dalfopristin for injection), Aventis Products NDA 50-747/S-002 3/13/02 3/29/02 SYNERCID I.V. (quinupristin and dalfopristin for injection), Rhone Poulenc Rorer NDA 50-747 and NDA 50-748 9/21/99 10/6/99 &10/6/99 9/24/99 & 9/24/99 7/18/01 SYNERCID I.V. Indications: for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia (Subpart H; NDA 50-747) and Complicated Skin and Skin Structure infections caused by Staphylococcus aureus (methicillin susceptible) or Streptococcus pyogenes (NDA 50-748). DALFOPRISTIN; QUINUPRISTIN Iv (Infusion) 350MG/VIAL;150MG/VIAL SYNERCID KING

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