MedPath
FDA Approval

Tamsulosin Hydrochloride

July 20, 2012

HUMAN PRESCRIPTION DRUG LABEL

Tamsulosin(0.4 mg in 1 1)

Registrants (1)

Teva Pharmaceuticals USA Inc

118234421

Manufacturing Establishments (1)

Blenheim Pharmacal, Inc.

MedVantx, Inc.

Teva Pharmaceuticals USA Inc

171434587

Products (1)

Tamsulosin Hydrochloride

66116-435

ANDA077630

ANDA (C73584)

ORAL

July 20, 2012

Code: 11SV1951MRClass: ACTIBQuantity: 0.4 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
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