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
NDC Product Code54436-112
Application NumberNDA208088
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 31, 2022
Generic Nametestosterone undecanoate
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