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Drug Product Composition: Premarin

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$ API Ref.Price (USD/KG) : 1,062Xls

USFDA APPLICATION NUMBER - 4782 / DOSAGE - TABLET;ORAL - 0.9MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTROGENS, CONJUGATED(UNII: IU5QR144QX)
(ESTROGENS, CONJUGATED - UNII:IU5QR144QX)
ESTROGENS, CONJUGATED0.9mg | 0.3mg | 1.25mg | 0.45mg

Inactive Ingredients

Ingredient Name
Teva Women's Health, Inc.
A-S Medication Solutions
A-S Medication Solutions LLC
Avera McKennan Hospital
Cardinal Health
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
ALUMINUM OXIDE(LMI26O6933)      
ASCORBYL PALMITATE(QN83US2B0N)      
BUTYLATED HYDROXYANISOLE(REK4960K2U)      
CARNAUBA WAX(R12CBM0EIZ) 
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)  
D&C RED NO. 30(2S42T2808B)    
D&C RED NO. 7(ECW0LZ41X8)    
D&C YELLOW NO. 10(35SW5USQ3G)  
EDETATE DISODIUM(7FLD91C86K)      
ETHYLCELLULOSES(7Z8S9VYZ4B)      
FD&C BLUE NO. 1(H3R47K3TBD)      
FD&C BLUE NO. 2(L06K8R7DQK)  
FD&C RED NO. 40(WZB9127XOA)    
FD&C YELLOW NO. 6(H77VEI93A8)    
FERRIC OXIDE RED(1K09F3G675)      
FERRIC OXIDE YELLOW(EX438O2MRT)      
FERROSOFERRIC OXIDE(XM0M87F357)    
GLYCERIN(PDC6A3C0OX)      
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)      
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)    
HYDROXYPROPYL CELLULOSE(RFW2ET671P)     
HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2) 
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)      
HYPROMELLOSE 2910 (4000 MPA.S)(RN3152OP35)      
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)      
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)      
POLYSORBATE 80(6OZP39ZG8H)      
POWDERED CELLULOSE(SMD1X3XO9M) 
SILICON DIOXIDE(ETJ7Z6XBU4)      
SUCROSE(C151H8M554) 
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)      
TRIBASIC CALCIUM PHOSPHATE(91D9GV0Z28) 
WATER(059QF0KO0R)