APPLICATION
ANDA205654
TYPE
ANDA
ORIGINAL APPROVAL
2020-08-14
LATEST ACTION
2025-06-17
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 1GM · SUPPOSITORY · RECTAL
Approval history
2025-06-17Labeling · Supplement 6 · standardAP
2024-08-22Labeling · Supplement 4 · standardAP
2024-08-22Labeling · Supplement 3 · standardAP
2024-08-22Labeling · Supplement 1 · standardAP
2020-08-14UNKNOWN · 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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