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Setid 986dc112 B97b 44a3 Bfaf 074f906f8bb2 Applno 21016 Form Tablet Oral Dosage Eq 40mg Base - Drug Product Composition: Eletriptan Hydrobromide

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$ API Ref.Price (USD/KG) : 5,553Xls

USFDA APPLICATION NUMBER - 21016 / DOSAGE - TABLET;ORAL - EQ 40MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELETRIPTAN HYDROBROMIDE(UNII: M41W832TA3)
(ELETRIPTAN - UNII:22QOO9B8KI)
ELETRIPTAN40mg

Inactive Ingredients

Ingredient Name
U.S. Pharmaceuticals
Zydus Pharmaceuticals USA Inc.
Teva Pharmaceuticals USA, Inc.
ALUMINUM OXIDE(LMI26O6933)  
ANHYDROUS LACTOSE(3SY5LH9PMK)  
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)  
FD&C BLUE NO. 2--ALUMINUM LAKE(4AQJ3LG584)  
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)  
FERRIC OXIDE YELLOW(EX438O2MRT)  
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)  
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)  
HYPROMELLOSES(3NXW29V3WO)  
LACTOSE MONOHYDRATE(EWQ57Q8I5X) 
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)  
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE 112(X7XJ6RM9Q2)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) 
POLYDEXTROSE(VH2XOU12IE)  
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)  
POVIDONE K30(U725QWY32X)  
SILICON DIOXIDE(ETJ7Z6XBU4)  
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)