Tamsulosin Hydrochloride

Registrants (1)

Aurobindo Pharma Limited

DUNS Number

650082092

Manufacturing Establishments (1)

Aurobindo Pharma Limited

Labeler

Rising Pharma Holdings, Inc.

Registrant

Aurobindo Pharma Limited

DUNS Number

650381903

Products (1)

NDC Product Code

57237-014

Application Number

ANDA202433

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 17, 2023

Ingredients

TamsulosinActive

Code: 11SV1951MRClass: ACTIBQuantity: 0.4 mg in 1 1

CALCIUM STEARATEInactive

Code: 776XM7047LClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

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Tamsulosin Hydrochloride

Registrants (1)

Manufacturing Establishments (1)

Products (1)

Tamsulosin Hydrochloride