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DEXMEDETOMIDINE

 
 
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 | Dexmedetomidine Hydrochloride, dexmedetomidine hydrochloride, Injectable; Injection, Mylan Institutional, Tentative Approval | Precedex, dexmedetomidine hydrochloride, Injectable; Injection, Hospira, Manufacturing Change or Addition | Precedex, dexmedetomidine hydrochloride, Injectable; Injection, Hospira, Efficacy Supplement with Clinical Data to Support

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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