APPLICATION
ANDA214242
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-15
LATEST ACTION
2024-10-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 375MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-10-24Labeling · Supplement 8 · standardAP
2024-04-04Labeling · Supplement 3 · standardAP
2022-06-03Labeling · Supplement 1 · standardAP
2021-07-15UNKNOWN · 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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