# IRBESARTAN
> **ANDA203071** · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2012-09-27
## Drug
- **FDA Application Number:** ANDA203071
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** IRBESARTAN
- **Generic name:** IRBESARTAN
- **Active ingredients:** IRBESARTAN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PRINSTON INC
- **Manufacturer:** Solco Healthcare U.S., LLC
- **First approval:** 2012-09-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203071)
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