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
aecd6c1b-d3e3-4568-b8cb-89954f0aee5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 23, 2010
Manufacturers
FDA
WOCKHARDT LIMITED
DUNS: 650069115
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 Code55648-516
Application NumberANDA078938
Product Classification
M
Marketing Category
C73584
G
Generic Name
TAMSULOSIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 23, 2010
FDA Product Classification
INGREDIENTS (1)
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 1
Code: 11SV1951MR
Classification: ACTIB