Testim
These highlights do not include all the information needed to use TESTIM safely and effectively. See full prescribing information for TESTIM. TESTIM (testosterone gel) for topical use, CIII Initial U.S. Approval: 1953
Approved
Approval ID
9f2aae1f-898d-4955-be31-678e0cf85395
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2021
Manufacturers
FDA
Endo Pharmaceuticals Inc.
DUNS: 178074951
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 Code66887-001
Application NumberNDA021454
Product Classification
M
Marketing Category
C73594
G
Generic Name
testosterone
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateAugust 14, 2021
FDA Product Classification
INGREDIENTS (1)
TESTOSTERONEActive
Quantity: 50 mg in 5 g
Code: 3XMK78S47O
Classification: ACTIB