TAMSULOSIN HYDROCHLORIDE
These highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. Approval: 1997
Approved
Approval ID
af558603-15f3-43e4-9ee5-9d38d59ef1c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TAMSULOSIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-034
Application NumberANDA078938
Product Classification
M
Marketing Category
C73584
G
Generic Name
TAMSULOSIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2012
FDA Product Classification
INGREDIENTS (1)
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 1
Code: 11SV1951MR
Classification: ACTIB