MedPath
FDA Approval

Dutasteride and tamsulosin hydrochloride

October 6, 2022

HUMAN PRESCRIPTION DRUG LABEL

Dutasteride(0.5 mg in 1 1)
Tamsulosin(0.4 mg in 1 1)

Registrants (1)

Zydus Pharmaceuticals USA Inc.

156861945

Manufacturing Establishments (1)

Zydus Lifesciences Limited

Zydus Pharmaceuticals USA Inc.

Zydus Pharmaceuticals USA Inc.

918596198

Products (1)

Dutasteride and tamsulosin hydrochloride

68382-640

ANDA207769

ANDA (C73584)

ORAL

October 6, 2022

Code: O0J6XJN02IClass: ACTIBQuantity: 0.5 mg in 1 1
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
Code: 11SV1951MRClass: ACTIBQuantity: 0.4 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDESInactive
Code: U72Q2I8C85Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10Class: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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