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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49502-475
Application NumberNDA022142
Product Classification
M
Marketing Category
C73594
G
Generic Name
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2019
FDA Product Classification
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