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… Factive (gemifloxacin mesylate) Tablets, 320 mg, GeneSoft NDA 21-158/S1 7/25/03 8/15/03 8/15/03 Factive (gemifloxacin mesylate) Tablets, 320 mg, LG Life Sciences, Ltd NDA 21-158 FACTIVE (gemifloxacin mesylate) Tablets, Parexel International, Labeling Revision   For the latest approval information, locate this drug using this index.