FDA ANDA · ANDA215067
MESALAMINE
Sponsor: AMNEAL
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APPLICATION
ANDA215067
TYPE
ANDA
ORIGINAL APPROVAL
2025-02-18
LATEST ACTION
2026-10-15
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 800MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-10-15Labeling · Supplement 6 · standardAP
2025-02-18UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →