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Setid 1c37faed Ae16 4efe A366 6cad776e935e Applno 207561 Form Tablet Oral Dosage 150mg 150mg 200mg Eq 10mg Base - Drug Product Composition: Elvitegravir

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USFDA APPLICATION NUMBER - 207561 / DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COBICISTAT(UNII: LW2E03M5PG)
(COBICISTAT - UNII:LW2E03M5PG)
COBICISTAT150mg
ELVITEGRAVIR(UNII: 4GDQ854U53)
(ELVITEGRAVIR - UNII:4GDQ854U53)
ELVITEGRAVIR150mg
EMTRICITABINE(UNII: G70B4ETF4S)
(EMTRICITABINE - UNII:G70B4ETF4S)
EMTRICITABINE200mg
TENOFOVIR ALAFENAMIDE FUMARATE(UNII: FWF6Q91TZO)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)
TENOFOVIR ANHYDROUS10mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
REMEDYREPACK INC.
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) 
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) 
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SODIUM LAURYL SULFATE(368GB5141J)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)