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Drug Product Composition: PREVIFEM

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$ API Ref.Price (USD/KG) : 40,931Xls

USFDA APPLICATION NUMBER - 17354 / DOSAGE - TABLET;ORAL-28 - 0.02MG;1MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL(UNII: 423D2T571U)
(ETHINYL ESTRADIOL - UNII:423D2T571U)
ETHINYL ESTRADIOL0.02mg | 0.03mg
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ)
(NORETHINDRONE - UNII:T18F433X4S)
NORETHINDRONE ACETATE1mg | 1.5mg

Inactive Ingredients

Ingredient Name
Aurobindo Pharma Limited
Afaxys Pharma, LLC.
RPK Pharmaceuticals, Inc.
Actavis Pharma, Inc.
Lupin Pharmaceuticals, Inc.
Mayne Pharma Inc.
Par Pharmaceutical
.ALPHA.-TOCOPHEROL(H4N855PNZ1)      
.ALPHA.-TOCOPHEROL, DL-(7QWA1RIO01)     
ACACIA(5C5403N26O)   
ALPHA-TOCOPHEROL(H4N855PNZ1)      
ALUMINUM OXIDE(LMI26O6933)      
ANHYDROUS LACTOSE(3SY5LH9PMK)     
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)     
CROSCARMELLOSE SODIUM(M28OL1HH48)   
D&C YELLOW NO. 10(35SW5USQ3G)   
FD&C BLUE NO. 1(H3R47K3TBD)     
FD&C YELLOW NO. 6(H77VEI93A8)     
FERROUS FUMARATE(R5L488RY0Q)   
HYPROMELLOSES(3NXW29V3WO)      
LACTOSE MONOHYDRATE(EWQ57Q8I5X)  
LACTOSE(J2B2A4N98G)      
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)     
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)      
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)     
POLYETHYLENE GLYCOL 400(B697894SGQ)      
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)      
POVIDONE K25(K0KQV10C35)     
POVIDONE K30(U725QWY32X)      
POVIDONE K90(RDH86HJV5Z)    
POVIDONE, UNSPECIFIED(FZ989GH94E)     
RAW SUGAR(8M707QY5GH)      
SILICON DIOXIDE(ETJ7Z6XBU4)    
SODIUM LAURYL SULFATE(368GB5141J)    
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)     
SPEARMINT(J7I2T6IV1N)      
STARCH, CORN(O8232NY3SJ)  
SUCRALOSE(96K6UQ3ZD4)      
SUCROSE(C151H8M554)  
SUGARCANE(81H2R5AOH3)      
TALC(7SEV7J4R1U)