# ROWASA
> **NDA019618** · New Drug Application · Sponsor: MYLAN SPECIALITY LP · Approved 1987-12-24
## Drug
- **FDA Application Number:** NDA019618
- **Application type:** New Drug Application
- **Brand name:** ROWASA
- **Generic name:** MESALAMINE
- **Active ingredients:** MESALAMINE
- **Dosage form:** ENEMA
- **Route:** RECTAL
- **Marketing status:** Prescription
- **Sponsor:** MYLAN SPECIALITY LP
- **Manufacturer:** ANI Pharmaceuticals, Inc.
- **First approval:** 1987-12-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019618)
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*MORVS · CC0 1.0*