Propulsid

NDA 20398, held by Janssen Pharms. Cisapride Monohydrate.

As of Nov 13, 2026, NDA 20398 (Propulsid), held by Janssen Pharms, was first approved by FDA on Sep 15, 1995, with 16 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1995
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Sep 15, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
PropulsidEQ 1MG BASE/ML · suspension;oral	Cisapride Monohydrate	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Mar 6, 2000	Supplement 22Labeling · Standard review	Approved	Review
Mar 6, 2000	Supplement 20Labeling · Standard review	Approved	Review
Nov 10, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 24, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 8, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 12, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 22, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 17, 1998	Supplement 15Labeling · Standard review	Approved	None posted
Aug 6, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 31, 1998	Supplement 14Labeling · Standard review	Approved	None posted
Jun 26, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 7, 1997	Supplement 8Labeling · Standard review	Approved	None posted
Oct 28, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 31, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 11, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Nov 1, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 15, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20398
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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