Androgel
Androgel
Approved
Approval ID
77215d87-ad22-4169-bd5f-a453f10b21ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
testosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-112
Application NumberNDA021015
Product Classification
M
Marketing Category
C73594
G
Generic Name
testosterone
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJanuary 14, 2010
FDA Product Classification
INGREDIENTS (6)
TESTOSTERONEActive
Quantity: 10 mg in 1 g
Code: 3XMK78S47O
Classification: ACTIB
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT