APPLICATION
ANDA216941
TYPE
ANDA
ORIGINAL APPROVAL
2023-05-30
LATEST ACTION
2025-01-23
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 4GM/60ML · ENEMA · RECTAL
Approval history
2025-01-23Labeling · Supplement 4 · standardAP
2024-04-12Labeling · Supplement 1 · standardAP
2023-05-30UNKNOWN · 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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