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FDA NDA · NDA021595

SANCTURA

Sponsor: ALLERGAN

APPLICATION
NDA021595
TYPE
NDA
ORIGINAL APPROVAL
2004-05-28
LATEST ACTION
2012-07-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SANCTURA · ReferenceDiscontinued
TROSPIUM CHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2012-07-23Labeling · Supplement 9 · standard — Letter ↗AP
2012-07-23Labeling · Supplement 8 · standard — Label ↗AP
2011-09-14Labeling · Supplement 6 · standard — Label ↗AP
2011-01-31Labeling · Supplement 7 · standard — Letter ↗AP
2009-06-01Labeling · Supplement 5 · standard — Label ↗AP
2006-12-07Labeling · Supplement 3 · standard — Letter ↗AP
2006-09-05Labeling · Supplement 2 · standard — Label ↗AP
2005-03-11Labeling · Supplement 1 · standard — Label ↗AP
2004-05-28Type 1 - New Molecular Entity · 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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