APPLICATION
ANDA207271
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-20
LATEST ACTION
2024-03-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 375MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-03-01Labeling · Supplement 7 · standardAP
2024-03-01Labeling · Supplement 4 · standardAP
2022-06-03Labeling · Supplement 3 · standardAP
2022-06-03Labeling · Supplement 1 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.