Razadyne

NDA 21224, held by Janssen Pharms. Galantamine Hydrobromide.

As of Nov 14, 2026, NDA 21224 (Razadyne), held by Janssen Pharms, was first approved by FDA on Jun 22, 2001, with 16 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2001
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
Jun 22, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Razadyne4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Galantamine Hydrobromide	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Feb 14, 2017	Supplement 30Labeling · Standard review	Approved	Letter Label
Dec 15, 2015	Supplement 29Labeling · Standard review	Approved	Label Letter
Feb 9, 2015	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 28, 2013	Supplement 22Labeling · Standard review	Approved	Label Letter
May 21, 2013	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 1, 2012	Supplement 25Labeling · Standard review	Approved	Label Letter
Mar 1, 2012	Supplement 15Labeling · Standard review	Approved	Label Letter
Mar 1, 2012	Supplement 14Labeling · Standard review	Approved	Label Letter
Apr 27, 2006	Supplement 12Labeling · Standard review	Approved	Letter
Apr 27, 2006	Supplement 11Labeling · Standard review	Approved	Letter
Apr 27, 2006	Supplement 10Labeling · Standard review	Approved	Letter
Apr 27, 2006	Supplement 8Labeling · Standard review	Approved	Letter
May 2, 2005	Supplement 9Labeling · Standard review	Approved	Letter
Sep 3, 2003	Supplement 5Labeling · Standard review	Approved	Letter
Apr 24, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 19, 2002	Supplement 3Labeling · Standard review	Approved	Letter
Jun 22, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21224
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