Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
These highlights do not include all the information needed to use EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
98342153-b9de-4318-aac4-9f8d19590cd7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2020
Manufacturers
FDA
Laurus Labs Limited
DUNS: 915075687
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42385-929
Application NumberANDA213038
Product Classification
M
Marketing Category
C73584
G
Generic Name
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2019
FDA Product Classification
INGREDIENTS (14)
LAMIVUDINEActive
Quantity: 300 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
EFAVIRENZActive
Quantity: 400 mg in 1 1
Code: JE6H2O27P8
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT