# IRBESARTAN AND HYDROCHLOROTHIAZIDE
> **ANDA091370** · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2012-10-15
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091370)
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