Razadyne Er

NDA 21615, held by Janssen Pharms. Galantamine Hydrobromide.

As of Nov 15, 2026, NDA 21615 (Razadyne Er), held by Janssen Pharms, was first approved by FDA on Apr 1, 2005, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 1, 2005
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Apr 1, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


Razadyne ErEQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Galantamine Hydrobromide	DiscontinuedReference drug
Razadyne ErEQ 16MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Galantamine Hydrobromide	DiscontinuedReference drug
Razadyne ErEQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, extended release;oral	Galantamine Hydrobromide	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Sep 26, 2022	Supplement 27Labeling · Standard review	Approved	Letter Label
Aug 3, 2021	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 20, 2020	Supplement 25Labeling · Standard review	Approved	Letter
Feb 21, 2020	Supplement 24Labeling · Standard review	Approved	Label Letter
Feb 14, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Dec 15, 2015	Supplement 22Labeling · Standard review	Approved	Letter Label
Feb 9, 2015	Supplement 21Labeling · Standard review	Approved	Letter Label
Jun 28, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
May 21, 2013	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 1, 2012	Supplement 18Labeling · Standard review	Approved	Label Letter
Mar 1, 2012	Supplement 9Labeling · Standard review	Approved	Label Letter
Mar 1, 2012	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 27, 2006	Supplement 5Labeling · Standard review	Approved	Letter
Apr 27, 2006	Supplement 4Labeling · Standard review	Approved	Letter
Apr 27, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Apr 27, 2006	Supplement 1Labeling · Standard review	Approved	Letter
May 2, 2005	Supplement 2Labeling · Standard review	Approved	Letter
Apr 1, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21615
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