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FDA Approval

Uroxatral

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

FDA Approval Summary

Company
Stat Rx USA
DUNS: 786036330
Effective Date
October 27, 2009
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Alfuzosin(10 mg in 1 1)

Products1

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

Uroxatral

Product Details

NDC Product Code
16590-279
Application Number
NDA021287
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 27, 2009
AlfuzosinActive
Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1
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