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.

NDC Product Code21695-112

Application NumberNDA021015

Marketing CategoryC73594

Route of AdministrationTRANSDERMAL

Effective DateJanuary 14, 2010

Generic Nametestosterone

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