Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
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Product Details
NDC Product Code
49502-425Application Number
NDA208255Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 9, 2019EfavirenzActive
Code: JE6H2O27P8Class: ACTIBQuantity: 400 mg in 1 1
LamivudineActive
Code: 2T8Q726O95Class: ACTIBQuantity: 300 mg in 1 1
Tenofovir disoproxilActive
Code: OTT9J7900IClass: ACTIBQuantity: 300 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT