FDA NDA · NDA021025

EXELON

Sponsor: NOVARTIS

APPLICATION

NDA021025

TYPE

NDA

ORIGINAL APPROVAL

2000-04-21

LATEST ACTION

2018-12-18

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

EXELON · ReferenceDiscontinued

RIVASTIGMINE TARTRATE EQ 2MG BASE/ML · SOLUTION · ORAL

2018-12-18Labeling · Supplement 24 · standard — Label ↗AP

2016-11-02Labeling · Supplement 23 · standard — Letter ↗AP

2015-02-03Labeling · Supplement 22 · standard — Letter ↗AP

2013-10-01Labeling · Supplement 18 · standard — Label ↗AP

2013-10-01Labeling · Supplement 20 · standard — Label ↗AP

2013-10-01Labeling · Supplement 19 · standard — Label ↗AP

2006-06-27Efficacy · Supplement 8 · unknown — Review ↗AP

2004-09-21Labeling · Supplement 7 · standard — Letter ↗AP

2004-05-05Labeling · Supplement 6 · standard — Letter ↗AP

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 — Review ↗AP

2000-07-11Manufacturing (CMC) · Supplement 1 · standardAP

2000-04-21Type 3 - New Dosage Form · Original · standard — Letter ↗AP

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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