Application Nr Approved Date Route Status External Links
ANDA209390 None Transdermal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Warning: Secondary Exposure To Testosterone See Full Prescribing Information For Complete Boxed Warning. Virilization Has Been Reported In Children Who Were Secondarily Exposed To Testosterone Gel ( 5.2 , 6.2 ). Children Should Avoid Contact With Unwashed Or Unclothed Application Sites In Men Using Testosterone Gel ( 2.2 , 5.2 ). Healthcare Providers Should Advise Patients To Strictly Adhere To Recommended Instructions For Use ( 2.2 , 5.2 , 17 ). Testosterone Gel 1.62% Is Indicated For Replacement Therapy In Males For Conditions Associated With A Deficiency Or Absence Of Endogenous Testosterone: Primary Hypogonadism (congenital Or Acquired) ( 1 ) Hypogonadotropic Hypogonadism (congenital Or Acquired) ( 1 ) Limitations Of Use: Safety And Efficacy Of Testosterone Gel 1.62% In Men With “age-Related Hypogonadism” Have Not Been Established. ( 1 ) Safety And Efficacy Of Testosterone Gel 1.62% In Males Less Than 18 Years Old Have Not Been Established. ( 1 , 8.4 ) Topical Testosterone Products May Have Different Doses, Strengths, Or Application Instructions That May Result In Different Systemic Exposure. ( 1 , 12.3 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Testosterone TESTOSTERONE ZINC490791

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