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… 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 | Precedex (dexmedetomidine hydrochloride) Injection, Hospira, Inc., Labeling Revision | Dexmedetomidine Hydrochloride Injection, Sandoz, Inc., Tentative Approval| Dexmedetomidine Hydrochloride Injection, Akorn Inc., Tentative Approval | Dexmedetomidine Hydrochloride, dexmedetomidine hydrochloride, Injectable; Injection, Caraco, 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com