FDA NDA · NDA019618
MESALAMINE
Sponsor: MYLAN SPECIALITY LP
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APPLICATION
NDA019618
TYPE
NDA
ORIGINAL APPROVAL
1987-12-24
LATEST ACTION
2026-10-14
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Prescription, Discontinued
Products
ROWASA · ReferencePrescription
MESALAMINE 4GM/60ML · ENEMA · RECTAL
SFROWASA · ReferenceDiscontinued
MESALAMINE 4GM/60ML · ENEMA · RECTAL
Approval history
2016-03-24Manufacturing (CMC) · Supplement 22 · priorityAP
2002-07-26Manufacturing (CMC) · Supplement 15 · priorityAP
2001-10-01Labeling · Supplement 13 · standardAP
1996-07-22Manufacturing (CMC) · Supplement 11 · priorityAP
1993-11-22Labeling · Supplement 8AP
1992-03-31Manufacturing (CMC) · Supplement 6 · priorityAP
1992-02-19Labeling · Supplement 7AP
1991-08-20Manufacturing (CMC) · Supplement 5 · priorityAP
1989-05-24Labeling · Supplement 2AP
1988-11-07Manufacturing (CMC) · Supplement 1 · priorityAP
1987-12-24Type 1 - New Molecular Entity · Original · priorityAP
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