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FDA Approval

Alfuzosin hydrochloride

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

FDA Approval Summary

Effective Date
March 25, 2022
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.

Alfuzosin hydrochloride

Product Details

NDC Product Code
29300-155
Application Number
ANDA203192
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 25, 2022
AlfuzosinActive
Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZIClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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