← FDA DRUG APPROVALS

FDA NDA · NDA021615

RAZADYNE ER

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021615
TYPE
NDA
ORIGINAL APPROVAL
2005-04-01
LATEST ACTION
2022-09-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

RAZADYNE ER · ReferenceDiscontinued
GALANTAMINE HYDROBROMIDE EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
RAZADYNE ER · ReferenceDiscontinued
GALANTAMINE HYDROBROMIDE EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
RAZADYNE ER · ReferenceDiscontinued
GALANTAMINE HYDROBROMIDE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2022-09-26Labeling · Supplement 27 · standard — Letter ↗AP
2021-08-03Labeling · Supplement 26 · standard — Letter ↗AP
2020-03-20Labeling · Supplement 25 · standard — Letter ↗AP
2020-02-21Labeling · Supplement 24 · standard — Letter ↗AP
2017-02-14Labeling · Supplement 23 · standard — Letter ↗AP
2015-12-15Labeling · Supplement 22 · standard — Letter ↗AP
2015-02-09Labeling · Supplement 21 · standard — Letter ↗AP
2013-06-28Labeling · Supplement 16 · standard — Label ↗AP
2013-05-21Manufacturing (CMC) · Supplement 19 · standardAP
2012-03-01Labeling · Supplement 9 · standard — Label ↗AP
2012-03-01Labeling · Supplement 18 · standard — Letter ↗AP
2012-03-01Labeling · Supplement 8 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 5 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 3 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 1 · standard — Letter ↗AP
2006-04-27Labeling · Supplement 4 · standard — Letter ↗AP
2005-05-02Labeling · Supplement 2 · standard — Letter ↗AP
2005-04-01Type 3 - New Dosage Form · 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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