← FDA Drug Approvals (Drugs@FDA)
MESALAMINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2025-04-16
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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