APPLICATION
ANDA202065
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-12
LATEST ACTION
2024-05-31
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 1GM · SUPPOSITORY · RECTAL
Approval history
2024-05-31Labeling · Supplement 5 · standardAP
2023-09-07Labeling · Supplement 2 · standardAP
2023-09-07Labeling · Supplement 3 · standardAP
2021-11-30Labeling · 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.
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