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… Precedex (dexmedetomidine hcl injection), 100 mcg/mL, supplied in 2 mL vials and 2 mL ampules/administered by infusion, Abbott NDA 21-038 12/17/99 1/3/00 1/3/00 7/26/01 Precedex Indication: Sedation for adult patients in ICU setting   For the latest approval information, locate this drug using this index.