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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 View updates.                                                                       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 | VOIP © 2012 Betterchem.com