17beta-N-(2,5-bis(trifluoromethyl))phenyl-carbamoyl-4-aza-5alpha-androst-1-en-3-one

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CAPSULE;ORAL - 0.5MG, CAPSULE;ORAL - 0.5MG;0.4MG

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USFDA APPLICATION NUMBER - 22460 / DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DUTASTERIDE(UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I)	DUTASTERIDE	0.5mg
TAMSULOSIN HYDROCHLORIDE(UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)	TAMSULOSIN HYDROCHLORIDE	0.4mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Prasco Laboratories
ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(U72Q2I8C85)
CARRAGEENAN(5C69YCD2YJ)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
GLYCERIN(PDC6A3C0OX)
GLYCERYL CAPRYLOCAPRATE(U72Q2I8C85)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LECITHIN, SOYBEAN(1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POTASSIUM CHLORIDE(660YQ98I10)
PROPYLENE GLYCOL(6DC9Q167V3)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIETHYL CITRATE(8Z96QXD6UM)

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Setid 27bbcda6 72ba 40b4 82d6 8d1efb3a85a2 Applno 22460 Form Capsule Oral Dosage 0 5mg 0 4mg - Drug Product Composition: 17beta-N-(2,5-bis(trifluoromethyl))phenyl-carbamoyl-4-aza-5alpha-androst-1-en-3-one