approval · primary record
MESALAMINE
FDA · NDA · 2026-10-14
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-10-14 |
| Approval events | 1 |
| Brand | ROWASA |
| Sponsor | MYLAN SPECIALITY LP |
| Route | RECTAL |
Approval history
1 action on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-10-14 | FDA | NDA | ROWASA | MYLAN SPECIALITY LP | RECTAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:27:54.870Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:mesalamine
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Mesalamine · compound