Rowasa

NDA 19919, held by Meda Pharms. Mesalamine.

As of Nov 14, 2026, NDA 19919 (Rowasa), held by Meda Pharms, was first approved by FDA on Dec 18, 1990, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1990
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 18, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Rowasa500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · suppository;rectal	Mesalamine	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Oct 1, 2001	Supplement 4Labeling · Standard review	Approved	None posted
Aug 8, 1997	Supplement 2Manufacturing · Standard review	Approved	Review
Feb 19, 1992	Supplement 1Labeling · Standard review	Approved	None posted
Dec 18, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19919
Drugs@FDA: Overview at FDA
Company: Meda Pharmaceuticals

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