TESTOSTERONE
These highlights do not include all the information needed to use TESTOSTERONE TOPICAL SOLUTION safely and effectively. See full prescribing information for TESTOSTERONE TOPICAL SOLUTION. TESTOSTERONE topical solution, for topical use CIIIInitial U.S. Approval:1953
Approved
Approval ID
e39289aa-681c-47ec-9461-52e7f17e5d71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-488
Application NumberANDA212882
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateDecember 8, 2023
Generic NameTESTOSTERONE
INGREDIENTS (5)
TESTOSTERONEActive
Quantity: 30 mg in 1.5 mL
Code: 3XMK78S47O
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
OCTISALATEInactive
Code: 4X49Y0596W
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT