Testosterone
These highlights do not include all the information needed to use TESTOSTERONE GEL safely and effectively. See full prescribing information for TESTOSTERONE GEL . TESTOSTERONE gel , for topical use CIII Initial U.S. Approval: 1953
Approved
Approval ID
5834d34f-839d-412c-b74c-da1dad2cfa88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 20, 2019
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0591-3217
Application NumberANDA076737
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMay 20, 2019
Generic NameTestosterone
INGREDIENTS (6)
TESTOSTERONEActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Testosterone
PRODUCT DETAILS
NDC Product Code0591-2921
Application NumberANDA076737
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMay 20, 2019
Generic NameTestosterone
INGREDIENTS (6)
TESTOSTERONEActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Testosterone
PRODUCT DETAILS
NDC Product Code0591-3216
Application NumberANDA076737
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMay 20, 2019
Generic NameTestosterone
INGREDIENTS (6)
TESTOSTERONEActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT