Raltegravir Potassium

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ACTIVE PHARMA INGREDIENTS

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FINISHED DOSAGE FORMULATIONS

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 400MG BASE, TABLET;ORAL - EQ 600MG BASE

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USFDA APPLICATION NUMBER - 22145 / DOSAGE - TABLET;ORAL - EQ 600MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RALTEGRAVIR POTASSIUM(UNII: 43Y000U234) (RALTEGRAVIR - UNII:22VKV8053U)	RALTEGRAVIR	400mg

Inactive Ingredients

Ingredient Name	REMEDYREPACK INC.	A-S Medication Solutions	Avera McKennan Hospital
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLOXAMER 407(TUF2IVW3M2)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Raltegravir Potassium