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CAROSPIR (nda209478)- (25MG/5ML)

SPIRONOLACTONE CMP DEV LLC
25MG/5ML
Yes Yes
2036-Oct-28 Expired
None None
None No
CAROSPIR is an antagonist of aldosterone 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 cirrhotic patients when edema is not responsive to fluid and sodium restrictions
1 0 1
Total Other Developers 7
Drugs with Suitability No
25MG/5ML ** ** Up - 1
NDA Sales Available Total Generic Sales Available
Yes 1
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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