JALYN
These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN.JALYN (dutasteride and tamsulosin hydrochloride) CapsulesInitial U.S. Approval: 2010
Approved
Approval ID
f96c6acd-4d02-4ece-bd54-2d5a35aab7f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 16, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dutasteride and tamsulosin hydrochloride
PRODUCT DETAILS
NDC Product Code54868-6328
Application NumberNDA022460
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 16, 2012
Generic Namedutasteride and tamsulosin hydrochloride
INGREDIENTS (17)
DUTASTERIDEActive
Quantity: 0.5 mg in 1 1
Code: O0J6XJN02I
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 1
Code: 11SV1951MR
Classification: ACTIB
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT