# IRBESARTAN
> **ANDA219539** · Abbreviated New Drug Application (Generic) · Sponsor: MSN · Approved 2025-11-04
## Drug
- **FDA Application Number:** ANDA219539
- **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:** MSN
- **Manufacturer:** Novadoz Pharmaceuticals LLC
- **First approval:** 2025-11-04
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219539)
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