MedPath
FDA Approval

Uroxatral

August 30, 2012

HUMAN PRESCRIPTION DRUG LABEL

Alfuzosin(10 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (1)

Uroxatral

54868-5046

NDA021287

NDA (C73594)

ORAL

August 30, 2012

silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
povidoneInactive
Code: FZ989GH94EClass: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
hydrogenated castor oilInactive
Code: ZF94AP8MEYClass: IACT
AlfuzosinActive
Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1
ethylcellulose (100 mpa.s)Inactive
Code: 47MLB0F1MVClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
ferric oxide yellowInactive
Code: EX438O2MRTClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
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