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HYDROCHLOROTHIAZIDE; IRBESARTAN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CIPLA LIMITED · Approved 2012-09-28

Drug application

FDA Application #
ANDA201616
Application type
Abbreviated New Drug Application (Generic)
Brand name
HYDROCHLOROTHIAZIDE; IRBESARTAN
Generic name
Hydrochlorothiazide
Active ingredients
HYDROCHLOROTHIAZIDE; IRBESARTAN
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
CIPLA LIMITED
First approval
2012-09-28

Source

Authoritative
Drugs@FDA application overview
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