testosterone
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .TESTOSTERONE topical solution, for topical use CIIIInitial U.S. Approval: 1953
Approved
Approval ID
0e943d17-3bf1-405a-9830-27653bfbf44b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
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 Code24979-130
Application NumberANDA209836
Product Classification
M
Marketing Category
C73584
G
Generic Name
testosterone
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2021
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TESTOSTERONEActive
Quantity: 30 mg in 1.5 mL
Code: 3XMK78S47O
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
OCTISALATEInactive
Code: 4X49Y0596W
Classification: IACT