SYMFI
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
81a55dd9-78a8-49c3-88ab-8f5bffafa359
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2019
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.
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
PRODUCT DETAILS
NDC Product Code49502-475
Application NumberNDA022142
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 15, 2019
Generic NameEfavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
EFAVIRENZActive
Quantity: 600 mg in 1 1
Code: JE6H2O27P8
Classification: ACTIB
LAMIVUDINEActive
Quantity: 300 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT