Propulsid Quicksolv

NDA 20767, held by Janssen Pharma. Cisapride Monohydrate.

As of Nov 13, 2026, NDA 20767 (Propulsid Quicksolv), held by Janssen Pharma, was first approved by FDA on Nov 7, 1997, with 9 approved supplements and 0 published complete response letters.

First approved: Nov 7, 1997
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Nov 7, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propulsid QuicksolvEQ 20MG BASE · tablet, orally disintegrating;oral	Cisapride Monohydrate	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Mar 6, 2000	Supplement 9Labeling · Standard review	Approved	Review
Mar 6, 2000	Supplement 11Labeling · Standard review	Approved	Review
Nov 10, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 20, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 12, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 22, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 17, 1998	Supplement 5Labeling · Standard review	Approved	None posted
Jul 31, 1998	Supplement 4Labeling · Standard review	Approved	None posted
Jun 26, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 7, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20767
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