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Setid 2e8a4f62 64c9 4cbc 93ac 994e48389bb6 Applno 17354 Form Tablet Oral 28 Dosage 0 02mg 1mg - Drug Product Composition: TRIPHASIL-21

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$ API Ref.Price (USD/KG) : 3,904Xls

USFDA APPLICATION NUMBER - 17354 / DOSAGE - TABLET;ORAL-28 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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
Actavis Pharma, Inc.
Mayne Pharma Inc.
RPK Pharmaceuticals, Inc.
ACACIA(5C5403N26O)
D&C YELLOW NO. 10(35SW5USQ3G) 
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C YELLOW NO. 6(H77VEI93A8) 
FERROUS FUMARATE(R5L488RY0Q)  
LACTOSE(J2B2A4N98G)  
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) 
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)  
POVIDONE, UNSPECIFIED(FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)  
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554) 
SUGARCANE(81H2R5AOH3)  
TALC(7SEV7J4R1U)