Aveed
These highlights do not include all the information needed to use AVEED safely and effectively. See full prescribing information for AVEED. AVEED (testosterone undecanoate) injection, CIIIInitial U.S. Approval: 1953
Approved
Approval ID
f80f025b-17d8-40af-8739-20ce07902045
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 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 undecanoate
PRODUCT DETAILS
NDC Product Code67979-511
Application NumberNDA022219
Marketing CategoryC73594
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 10, 2023
Generic Nametestosterone undecanoate
INGREDIENTS (3)
TESTOSTERONE UNDECANOATEActive
Quantity: 250 mg in 1 mL
Code: H16A5VCT9C
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT