TESTAGEN- testosterone aerosol, spray 
Langford Research Institute

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Clinical Trial Materials for IND101271

Testagen(R) TDS Testosterone 5% Instructions for use

To be applied in accordance with enclosed instructions.

Testagen TDS Testosterone 5% Principal Display panel - Clinical trial materials

For Clinical Trial Use Only
EudraCT No: 2013-001766-42
PARC-Testosterone-D-01/09/13
Subject number: S/R_____
For topical application
To be applied in accordance with enclosed instructions
Investigator: Prof R Langford
Use by: 07 / 2017
Batch no: TDST-004
Keep out of the reach of and avoid contact with women & children
Store at room temp. TLC Advanced Therapies Centre Pharm.
Caution – New Drug – Limited by Law to Investigational Use

See Image CDER Testagen Label

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TESTAGEN 
testosterone aerosol, spray
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70304-001
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
(1,2,6,7-3H)TESTOSTERONE (UNII: P57HP4MCQZ) ((1,2,6,7-3H)TESTOSTERONE - UNII:P57HP4MCQZ) (1,2,6,7-3H)TESTOSTERONE50 mg  in 50 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70304-001-0150 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
INDIND10127112/30/2016
Labeler - Langford Research Institute (933253341)
Registrant - Langford Research Institute (933253341)
Establishment
NameAddressID/FEIBusiness Operations
Langford Research Institute933253341manufacture(70304-001)

Revised: 11/2015
Document Id: 44e4944f-3e81-5b60-e054-00144ff8d46c
Set id: 44e4944f-3e80-5b60-e054-00144ff8d46c
Version: 4
Effective Time: 20151124
 
Langford Research Institute