Raltegravir Potassium Salt

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 9 USDMF, 5 CEP/COS, 7 EU WC, 4 KDMF, 8 NDC API, 21 Listed Suppliers, $ API Reference Price

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5 Drugs in Development

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18 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

37 FDF Dossiers, 8 FDA Orange Book, 20 Europe, 3 Canada, 2 Australia, 3 South Africa, 1 Listed Dossiers

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 400MG 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)

Setid 90defbe0 19df 43ed B8e7 D75c473f53ec Applno 22145 Form Tablet Oral Dosage Eq 400mg Base - Drug Product Composition: Raltegravir Potassium Salt