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 Drug Recalls 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… Gemzar (gemcitabine HCl) for Injection, Eli Lilly NDA 20-509/S21 5/1/02 5/9/02 Gemzar (gemcitabine HCl) for Injection, Eli Lilly NDA 20-509/S13 1/6/03 1/23/03 1/23/03 Gemzar (gemcitabine HCl) for Injection, Eli Lilly NDA 20-509 SE1-005 8/26/98 8/28/98 8/28/98 Gemzar Indications: For use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer. Gemzar (gemcitabine HCl) for Injection, Eli Lilly and Company | Gemzar (gemcitabine HCl) for Injection, Eli Lilly and Co., Labeling Revision | Gemzar (gemcitabine HCl) Injection, Eli Lilly & Co., Efficacy Supplement w/Clinical Data | Gemzar (gemcitabine HCl) Injection, Eli Lilly, Labeling Revision | Gemcitabine Injection, Sicor Pharma, Tentative Approval | Gemcitabine Injection, Sicor Pharma, Tentative Approval | Gemcitabine Injection, Hospira Inc., Tentative Approval | Gemcitabine Injection, Sun Pharma, Tentative Approval ^ 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com