# MESALAMINE
> **ANDA219997** · Abbreviated New Drug Application (Generic) · Sponsor: DIFGEN PHARMS · Approved 2026-03-10
## Drug
- **FDA Application Number:** ANDA219997
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** MESALAMINE
- **Generic name:** Mesalamine
- **Active ingredients:** MESALAMINE
- **Dosage form:** CAPSULE, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** DIFGEN PHARMS
- **First approval:** 2026-03-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219997)
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