EPINEPHRINE HYPOSPRAY(R)- epinephrine bitartrate aerosol, spray 
Langford Research Institute

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Epinephrine HypoSpray

Epinephrine HypoSpray

For Topical Application. To be applied in

accordance with enclosed instructions.

Epinephrine HypoSpray

For Clinical Trial Use Only
EudraCT No: 2017-000000-00
Subject number: S/R _____
For topical application. To be applied in accordance with enclosed instructions
Investigator: Prof S. L. Chew
Use by: 07 / 2017
Batch no: TDSE-002
Store at room temperature
Barts Health Pharmacy Production
Caution – Limited by Law to Investigational Use
Mfr By LRI, Florida License 20337 NDC 070304-002-01

picture of sample labelSee CDER Direct Epi Label image

EPINEPHRINE HYPOSPRAY(R) 
epinephrine bitartrate aerosol, spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70304-002
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE1 mg  in 1 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70304-002-011 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/10/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
INDIND13247310/10/2016
Labeler - Langford Research Institute (933253341)
Registrant - Langford Research Institute (933253341)
Establishment
NameAddressID/FEIBusiness Operations
Langford Research Institute933253341manufacture(70304-002)

Revised: 12/2016
Document Id: 44e548cb-ff2e-14ef-e054-00144ff88e88
Set id: 44e548cb-ff2d-14ef-e054-00144ff88e88
Version: 1
Effective Time: 20161230
 
Langford Research Institute