← FDA Drug Approvals (Drugs@FDA)
MESALAMINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMTA · Approved 2023-06-06
Drug application
- FDA Application #
ANDA217533- 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
- AMTA
- Manufacturer
- Upsher-Smith Laboratories, LLC
- First approval
- 2023-06-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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