Tlando
These highlights do not include all the information needed to use TLANDO™ safely and effectively. See full prescribing information for TLANDO.TLANDO (testosterone undecanoate) capsules, for oral use, CIIIInitial U.S. Approval: 1953
Approved
Approval ID
479b55bd-2023-486a-8922-3b1de48b935c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Antares Pharma, Inc.
DUNS: 085369585
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54436-112
Application NumberNDA208088
Product Classification
M
Marketing Category
C73594
G
Generic Name
testosterone undecanoate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2022
FDA Product Classification
INGREDIENTS (11)
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TESTOSTERONE UNDECANOATEActive
Quantity: 112.5 mg in 1 1
Code: H16A5VCT9C
Classification: ACTIB
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
GLYCERYL MONOLINOLEATEInactive
Code: 4763AXI84L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT