APPLICATION
ANDA207873
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-09
LATEST ACTION
2025-03-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 400MG · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2025-03-06Labeling · Supplement 8 · standardAP
2023-09-20Labeling · Supplement 6 · standardAP
2023-09-20Labeling · Supplement 4 · standardAP
2023-09-20Labeling · Supplement 7 · 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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