Rowasa, Sfrowasa

Treats active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis. NDA 19618, held by Mylan Speciality LP. Mesalamine.

As of Nov 14, 2026, NDA 19618 (Rowasa, Sfrowasa), held by Mylan Speciality LP, was first approved by FDA on Dec 24, 1987, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 24, 1987
Review: Priority
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Mesalamine Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Dec 24, 1987	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Rowasa4GM/60ML · enema;rectal	Mesalamine	RxReference drug
Sfrowasa4GM/60ML · enema;rectal	Mesalamine	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 35Labeling · Standard review	Approved	Label Letter
Jul 30, 2024	Supplement 33Labeling · Standard review	Approved	Label Letter
Oct 24, 2023	Supplement 32Labeling · Standard review	Approved	Label
Nov 16, 2022	Supplement 30Labeling · Standard review	Approved	Letter Label
Nov 1, 2021	Supplement 29Labeling · Standard review	Approved	Letter Label
Jun 25, 2021	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 1, 2020	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 27, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 24, 2016	Supplement 22Manufacturing · Priority review	Approved	None posted
Jun 20, 2008	Supplement 18Manufacturing	Approved	Label Letter
Dec 29, 2005	Supplement 16Labeling · Standard review	Approved	Letter
Jul 26, 2002	Supplement 15Manufacturing · Priority review	Approved	None posted
Oct 1, 2001	Supplement 13Labeling · Standard review	Approved	None posted
Jul 22, 1996	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 22, 1993	Supplement 8Labeling	Approved	None posted
Mar 31, 1992	Supplement 6Manufacturing · Priority review	Approved	None posted
Feb 19, 1992	Supplement 7Labeling	Approved	None posted
Aug 20, 1991	Supplement 5Manufacturing · Priority review	Approved	None posted
May 24, 1989	Supplement 2Labeling	Approved	None posted
Nov 7, 1988	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 24, 1987	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19618
Drugs@FDA: Overview at FDA
Company: Mylan Specialty

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters