Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Synercid (quinupristin and dalfopristin) I.V., King Pharmaceuticals, Inc., Labeling Revision | Synercid (quinupristin and dalfopristin) Injection, King Pharmaceuticals, Inc., Labeling Revision | Synercid, quinupristin; dalfopristin, Injectable; Injection, King Pharms, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com