APPLICATION
ANDA220016
TYPE
ANDA
ORIGINAL APPROVAL
2026-03-31
LATEST ACTION
2026-03-31
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 4GM/60ML · ENEMA · RECTAL
Approval history
2026-03-31UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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