MedPath
FDA Approval

Stribild

March 20, 2017

HUMAN PRESCRIPTION DRUG LABEL

Elvitegravir(150 mg in 1 1)
Tenofovir disoproxil(300 mg in 1 1)
Emtricitabine(200 mg in 1 1)
Cobicistat(150 mg in 1 1)

Manufacturing Establishments (1)

Avera McKennan Hospital

Avera McKennan Hospital

068647668

Products (1)

Stribild

69189-1201

NDA203100

NDA (C73594)

ORAL

March 20, 2017

Code: 4GDQ854U53Class: ACTIBQuantity: 150 mg in 1 1
Code: OTT9J7900IClass: ACTIBQuantity: 300 mg in 1 1
Code: G70B4ETF4SClass: ACTIBQuantity: 200 mg in 1 1
Code: LW2E03M5PGClass: ACTIBQuantity: 150 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYDROXYPROPYL CELLULOSE (1200000 MW)Inactive
Code: RFW2ET671PClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
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