# MESALAMINE
> **ANDA215269** · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2025-04-16
## Drug
- **FDA Application Number:** ANDA215269
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** MESALAMINE
- **Generic name:** Mesalamine
- **Active ingredients:** MESALAMINE
- **Dosage form:** ENEMA
- **Route:** RECTAL
- **Marketing status:** Prescription
- **Sponsor:** NOVITIUM PHARMA
- **First approval:** 2025-04-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215269)
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