Testosterone
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for for topical use, CIII Initial U.S. Approval: 1953
Approved
Approval ID
fa29b98e-28a7-41f5-8fc7-718ea092de27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 14, 2018
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Testosterone
PRODUCT DETAILS
NDC Product Code70518-1171
Application NumberNDA203098
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateMay 14, 2018
Generic NameTestosterone
INGREDIENTS (5)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
ISOSTEARIC ACIDInactive
Code: X33R8U0062
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TESTOSTERONEActive
Quantity: 12.5 mg in 1.25 g
Code: 3XMK78S47O
Classification: ACTIB