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AVALIDE (nda020758)- (12.5MG;75MG,12.5MG;150MG,12.5MG;300MG,25MG;300MG)

HYDROCHLOROTHIAZIDE; IRBESARTAN SANOFI AVENTIS US
12.5MG;75MG,12.5MG;150MG,12.5MG;300MG,25MG;300MG
Yes No
2015-Dec-07 Expired
None None
None No
AVALIDE is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: • In patients not adequately controlled with monotherapy. • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
11 6 8
Total Other Developers 4
Drugs with Suitability No
12.5MG;75MG ** ** - - -
12.5MG;150MG ** ** - - 4
12.5MG;300MG ** ** - - 4
25MG;300MG ** ** - - -
NDA Sales Available Total Generic Sales Available
No 6
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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PRINSTON INC 43547-672 ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. 530732460 Manufacture Xunqiao Town, Linhai, Zhejiang 317024, China (CHN) CHN

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