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ALDACTAZIDE (nda012616)- (25MG;25MG,50MG;50MG)

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE PFIZER
25MG;25MG,50MG;50MG
No No
Expired Expired
None None
None No
ALDACTAZIDE is indicated for: Edematous conditions for patients with: *Congestive heart failure: • For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures; • The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate; • The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate. *Cirrhosis of the liver accompanied by edema and/or ascites: • Aldosterone levels may be exceptionally high in this condition. ALDACTAZIDE is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. The nephrotic syndrome: • For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response. *Essential hypertension: • For patients with essential hypertension in whom other measures are considered inadequate or inappropriate; • In hypertensive patients for the treatment of a diuretic-inducedhypokalemia when other measures are considered inappropriate; • ALDACTAZIDE is indicated for the treatment of hypertension, to lower blood pressure.
2 0 2
Total Other Developers 4
Drugs with Suitability No
25MG;25MG ** ** - - 2
50MG;50MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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