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Drug Product Composition: Prestwick3_000477

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$ API Ref.Price (USD/KG) : 244Xls

USFDA APPLICATION NUMBER - 210132 / DOSAGE - CAPSULE;ORAL - 1MG;100MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
estradiol(UNII: 4TI98Z838E)
(estradiol - UNII:4TI98Z838E)
estradiol0.5mg | 1mg
progesterone(UNII: 4G7DS2Q64Y)
(progesterone - UNII:4G7DS2Q64Y)
progesterone100mg | 100mg

Inactive Ingredients

Ingredient Name
Mayne Pharma LLC
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)
ETHYL ACETATE(76845O8NMZ)
FD&C RED NO. 40(WZB9127XOA)
GELATIN TYPE B BOVINE (200 BLOOM)(A7JR5F8DLH)
GELATIN, UNSPECIFIED(2G86QN327L)
GLYCERIN(PDC6A3C0OX)
GLYCERYL MONO AND DICAPRYLOCAPRATE(U72Q2I8C85)
ISOPROPYL ALCOHOL(ND2M416302)
LAUROYL PEG-32 GLYCERIDES(H5ZC52369M)
LECITHIN, SOYBEAN(1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ACETATE PHTHALATE(58QVG85GW3)
PROPYLENE GLYCOL(6DC9Q167V3)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)