← FDA Drug Approvals (Drugs@FDA)
IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2012-10-15
Drug application
- FDA Application #
ANDA091370- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Generic name
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Active ingredients
- HYDROCHLOROTHIAZIDE; IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALEMBIC
- Manufacturer
- Alembic Pharmaceuticals Limited
- First approval
- 2012-10-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown