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

For the latest approval information and links for this API, please see the main page.