← FDA DRUG APPROVALS

FDA NDA · NDA020823

EXELON

Sponsor: NOVARTIS

APPLICATION
NDA020823
TYPE
NDA
ORIGINAL APPROVAL
2000-04-21
LATEST ACTION
2018-12-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

EXELON · ReferenceDiscontinued
RIVASTIGMINE TARTRATE EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
EXELON · ReferenceDiscontinued
RIVASTIGMINE TARTRATE EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
EXELON · ReferenceDiscontinued
RIVASTIGMINE TARTRATE EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
EXELON · ReferenceDiscontinued
RIVASTIGMINE TARTRATE EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2018-12-18Labeling · Supplement 36 · standard — Label ↗AP
2016-11-02Labeling · Supplement 35 · standard — Letter ↗AP
2016-01-22Manufacturing (CMC) · Supplement 34 · standardAP
2015-11-13Manufacturing (CMC) · Supplement 33 · standardAP
2015-02-03Labeling · Supplement 32 · standard — Label ↗AP
2014-04-09Manufacturing (CMC) · Supplement 31 · standardAP
2013-10-01Labeling · Supplement 9 · standard — Letter ↗AP
2013-10-01Labeling · Supplement 28 · standard — Label ↗AP
2013-10-01Labeling · Supplement 29 · standard — Label ↗AP
2013-10-01Labeling · Supplement 27 · standard — Letter ↗AP
2013-03-21Manufacturing (CMC) · Supplement 30 · standardAP
2006-10-23Manufacturing (CMC) · Supplement 17AP
2006-06-27Efficacy · Supplement 16 · unknown — Label ↗AP
2004-09-21Labeling · Supplement 14 · standard — Letter ↗AP
2004-05-05Labeling · Supplement 12 · standard — Letter ↗AP
2002-10-24Manufacturing (CMC) · Supplement 7 · standardAP
2002-10-16Manufacturing (CMC) · Supplement 6 · standardAP
2002-01-28Manufacturing (CMC) · Supplement 4 · standardAP
2002-01-25Manufacturing (CMC) · Supplement 5 · standardAP
2001-01-31Manufacturing (CMC) · Supplement 2 · standardAP
2001-01-05Labeling · Supplement 3 · standard — Label ↗AP
2000-07-11Manufacturing (CMC) · Supplement 1 · standardAP
2000-04-21Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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