← FDA Drug Approvals (Drugs@FDA)
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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