APPLICATION
ANDA219864
TYPE
ANDA
ORIGINAL APPROVAL
2025-08-13
LATEST ACTION
2025-08-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 375MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
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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