← FDA DRUG APPROVALS

FDA NDA · NDA019618

MESALAMINE

Sponsor: MYLAN SPECIALITY LP

APPLICATION
NDA019618
TYPE
NDA
ORIGINAL APPROVAL
1987-12-24
LATEST ACTION
2024-07-30
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Prescription

Products

ROWASA · ReferencePrescription
MESALAMINE 4GM/60ML · ENEMA · RECTAL
SFROWASA · ReferencePrescription
MESALAMINE 4GM/60ML · ENEMA · RECTAL

Approval history

2024-07-30Labeling · Supplement 33 · standard — Letter ↗AP
2023-10-24Labeling · Supplement 32 · standard — Label ↗AP
2022-11-16Labeling · Supplement 30 · standard — Letter ↗AP
2021-11-01Labeling · Supplement 29 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 27 · standard — Label ↗AP
2020-10-01Labeling · Supplement 26 · standard — Letter ↗AP
2017-07-27Labeling · Supplement 23 · standard — Letter ↗AP
2016-03-24Manufacturing (CMC) · Supplement 22 · priorityAP
2008-06-20Manufacturing (CMC) · Supplement 18 — Label ↗AP
2005-12-29Labeling · Supplement 16 · standard — Letter ↗AP
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
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →