Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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).   For the latest approval information, locate this drug using this index.