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FDA NDA · NDA021169

RAZADYNE

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021169
TYPE
NDA
ORIGINAL APPROVAL
2001-02-28
LATEST ACTION
2021-08-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RAZADYNE · ReferenceDiscontinued
GALANTAMINE HYDROBROMIDE EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
RAZADYNE · ReferenceDiscontinued
GALANTAMINE HYDROBROMIDE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
RAZADYNE · ReferenceDiscontinued
GALANTAMINE HYDROBROMIDE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-08-03Labeling · Supplement 35 · standard — Letter ↗AP
2020-03-20Labeling · Supplement 34 · standard — Letter ↗AP
2020-02-21Labeling · Supplement 33 · standard — Letter ↗AP
2017-02-14Labeling · Supplement 32 · standard — Letter ↗AP
2015-12-15Labeling · Supplement 31 · standard — Label ↗AP
2015-02-09Labeling · Supplement 30 · standard — Label ↗AP
2013-06-28Labeling · Supplement 24 · standard — Letter ↗AP
2013-05-21Manufacturing (CMC) · Supplement 28 · standardAP
2012-03-01Labeling · Supplement 16 · standard — Label ↗AP
2012-03-01Labeling · Supplement 17 · standard — Label ↗AP
2012-03-01Labeling · Supplement 26 · standard — Label ↗AP
2006-04-27Labeling · Supplement 14 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 12 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 10 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 13 · standard — Letter ↗AP
2005-05-02Labeling · Supplement 11 · standard — Letter ↗AP
2003-09-03Labeling · Supplement 7 · standard — Letter ↗AP
2002-07-31Manufacturing (CMC) · Supplement 4 · standardAP
2002-04-19Labeling · Supplement 3 · standard — Letter ↗AP
2001-08-15Manufacturing (CMC) · Supplement 1 · standardAP
2001-02-28Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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