APPLICATION
ANDA214477
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-31
LATEST ACTION
2024-02-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 375MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-02-27Labeling · Supplement 2 · standardAP
2023-03-31UNKNOWN · 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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