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FDA Approval

Tamsulosin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
RedPharm Drug, Inc.
DUNS: 828374897
Effective Date
January 21, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tamsulosin(0.4 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

RedPharm Drug, Inc.

RedPharm Drug, Inc.

828374897

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tamsulosin Hydrochloride

Product Details

NDC Product Code
67296-1739
Application Number
ANDA204645
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 21, 2022
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
Code: 11SV1951MRClass: ACTIBQuantity: 0.4 mg in 1 1
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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