Androgel
These highlights do not include all the information needed to use AndroGel safely and effectively. See full prescribing information for AndroGel.AndroGel (testosterone gel) 1% for topical use CIIIInitial U.S. Approval: 1953
Approved
Approval ID
d466910c-9a76-44e8-8759-4717ec2c591f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Testosterone
PRODUCT DETAILS
NDC Product Code54868-5814
Application NumberNDA021015
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateDecember 15, 2011
Generic NameTestosterone
INGREDIENTS (6)
carbomer homopolymer type CInactive
Code: 4Q93RCW27E
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
testosteroneActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
Testosterone
PRODUCT DETAILS
NDC Product Code54868-4810
Application NumberNDA021015
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateDecember 15, 2011
Generic NameTestosterone
INGREDIENTS (6)
testosteroneActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
carbomer homopolymer type CInactive
Code: 4Q93RCW27E
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Testosterone
PRODUCT DETAILS
NDC Product Code54868-4792
Application NumberNDA021015
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateDecember 15, 2011
Generic NameTestosterone
INGREDIENTS (6)
testosteroneActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
carbomer homopolymer type CInactive
Code: 4Q93RCW27E
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT