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FDA NDA · NDA021224

RAZADYNE

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021224
TYPE
NDA
ORIGINAL APPROVAL
2001-06-22
LATEST ACTION
2017-02-14
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

RAZADYNEDiscontinued
GALANTAMINE HYDROBROMIDE 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2017-02-14Labeling · Supplement 30 · standard — Letter ↗AP
2015-12-15Labeling · Supplement 29 · standard — Label ↗AP
2015-02-09Labeling · Supplement 28 · standard — Letter ↗AP
2013-06-28Labeling · Supplement 22 · standard — Letter ↗AP
2013-05-21Manufacturing (CMC) · Supplement 26 · standardAP
2012-03-01Labeling · Supplement 14 · standard — Label ↗AP
2012-03-01Labeling · Supplement 25 · standard — Letter ↗AP
2012-03-01Labeling · Supplement 15 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 11 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 12 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 8 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 10 · standard — Letter ↗AP
2005-05-02Labeling · Supplement 9 · standard — Letter ↗AP
2003-09-03Labeling · Supplement 5 · standard — Letter ↗AP
2002-04-24Manufacturing (CMC) · Supplement 2 · standardAP
2002-04-19Labeling · Supplement 3 · standard — Letter ↗AP
2001-06-22Type 3 - New Dosage Form · Original · standard — Letter ↗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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