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ALDACTONE (nda012151)- (25MG,50MG,100MG)

SPIRONOLACTONE PFIZER
25MG,50MG,100MG
No No
Expired Expired
None None
None No
ALDACTONE is an aldosterone antagonist indicated for:  The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure  Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions  The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response.  Treatment of primary hyperaldosteronism for: o Short-term preoperative treatment o Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia
8 0 8
Total Other Developers 14
Drugs with Suitability No
25MG ** ** - - 8
50MG ** ** - - 8
100MG ** ** - - 8
NDA Sales Available Total Generic Sales Available
Yes 8
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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