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FDA NDA · NDA022083

RIVASTIGMINE

Sponsor: SANDOZ

APPLICATION
NDA022083
TYPE
NDA
ORIGINAL APPROVAL
2007-07-06
LATEST ACTION
2024-05-08
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

EXELON · ReferencePrescription
RIVASTIGMINE 9.5MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
EXELON · ReferencePrescription
RIVASTIGMINE 13.3MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
EXELON · ReferencePrescription
RIVASTIGMINE 4.6MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2024-05-08Labeling · Supplement 28 · standard — Letter ↗AP
2018-12-18Labeling · Supplement 26 · standard — Label ↗AP
2016-11-02Labeling · Supplement 23 · standard — Letter ↗AP
2015-06-24Manufacturing (CMC) · Supplement 21 · standardAP
2015-02-03Labeling · Supplement 20 · standard — Label ↗AP
2013-06-27Efficacy · Supplement 19 · standard — Label ↗AP
2013-03-13Manufacturing (CMC) · Supplement 18 · standardAP
2012-08-31Efficacy · Supplement 16 · standard — Review ↗AP
2010-08-27Labeling · Supplement 8 · unknown — Letter ↗AP
2007-07-06Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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