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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6328
Application NumberNDA022460
Product Classification
M
Marketing Category
C73594
G
Generic Name
dutasteride and tamsulosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2012
FDA Product Classification
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