CIMDUO
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2018
Approved
Approval ID
a300f04d-118f-4136-aaf3-ddfd00197f86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2021
Manufacturers
FDA
Mylan Specialty L.P.
DUNS: 194775557
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamivudine and Tenofovir Disoproxil Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49502-450
Application NumberNDA022141
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lamivudine and Tenofovir Disoproxil Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2018
FDA Product Classification
INGREDIENTS (10)
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
LAMIVUDINEActive
Quantity: 300 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT