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Drug Product Composition: Estradiol

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$ API Ref.Price (USD/KG) : 3,513Xls

USFDA APPLICATION NUMBER - 20907 / DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E)
ESTRADIOL1mg | 0.5mg
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ)
(NORETHINDRONE - UNII:T18F433X4S)
NORETHINDRONE ACETATE0.5mg | 0.1mg

Inactive Ingredients

Ingredient Name
Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals NY LLC
Gemini Laboratories, LLC
Novo Nordisk
COPOVIDONE K25-31(D9C330MD8B)  
COPOVIDONE(D9C330MD8B)  
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)   
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)   
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)   
HYPROMELLOSES(3NXW29V3WO) 
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TRIACETIN(XHX3C3X673)