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… 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 | Gemcitabine Hydrochloride Injection, TEVA Parenteral Medicines, Inc., Approval | Gemcitabine Injection, Hospira, Inc., Tentative Approval | Gemcitabine Injection, APP Pharmaceuticals, LLC, Tentative Approval | Gemcitabine Injection, Teva Parenteral Medicines, Inc., Tentative Approval | Gemcitabine Injection, Watson Laboratories, Inc., Tentative Approval | Gemcitabine Injection, Actavis Totowa, LLC, Tentative Approval | Gemcitabine Injection, Pliva Lachema, Tentative Approval | Gemzar (gemcitabine hydrochloride) Injection, Eli Lilly and Co., Labeling Revision | Gemcitabine Injection, Hospira, Inc., Approval | Gemcitabine Injection, Teva Parenteral Medicines, Inc., Approval | Gemcitabine Injection, Fresenius Kabi Oncology Plc., Tentative Approval | Gemzar (gemcitabine hydrochloride) Injection, Eli Lily and Co., Labeling Revision | Gemcitabine Injection, Bedford Laboratories, Tentative Approval | Gemcitabine Injection, APP Pharmaceuticals, LLC, Approval | Gemcitabine Injection, Fresenius Kabi Oncology Plc., Approval | Gemcitabine Injection, B&H Consulting Services, Inc., Tentative Approval | Gemcitabine Hydrochloride Injection, Actavis Totowa LLC, Approval | Gemcitabine Hydrochloride Injection, Dr. Reddy's Laboratories Ltd., Approval | Gemcitabine Hydrochloride Injection, Fresenius Kabi Oncology Plc, Approval | Gemcitabine Hydrochloride Injection, Hospira, Inc., Approval | Gemcitabine Hydrochloride Injection, Onco Therapies Ltd., Approval | Gemcitabine Hydrochloride Injection, Sun Pharma Global FZE, Approval | Gemcitabine Hydrochloride Injection, Watson Laboratories, Inc., Approval | Gemcitabine Hydrochloride Injection, Accord Healthcare Inc., Approval | Gemcitabine Injection, Hospira, Inc., 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com