APPLICATION
ANDA213377
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-19
LATEST ACTION
2024-01-31
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
MESALAMINEPrescription
MESALAMINE 1GM · SUPPOSITORY · RECTAL
Approval history
2024-01-31Labeling · Supplement 4 · standardAP
2023-09-12Labeling · Supplement 2 · standardAP
2020-03-19UNKNOWN · 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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