17-alpha-Ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, SYSTEM;INTRAUTERINE - 52MG, TABLET;ORAL - 0.02MG;0.1MG, SYSTEM;INTRAUTERINE - 52MG, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR, TABLET;ORAL - 1.5MG

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PATENTS & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 21225 / DOSAGE - SYSTEM;INTRAUTERINE - 52MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVONORGESTREL(UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)	LEVONORGESTREL	52mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Bayer HealthCare Pharmaceuticals Inc.
BARIUM SULFATE(25BB7EKE2E)
DIMETHICONE(92RU3N3Y1O)

Drug Product Composition: 17-alpha-Ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one