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FDA NDA · NDA022103

SANCTURA XR

Sponsor: ALLERGAN

APPLICATION
NDA022103
TYPE
NDA
ORIGINAL APPROVAL
2007-08-03
LATEST ACTION
2012-08-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

SANCTURA XR · ReferenceDiscontinued
TROSPIUM CHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2012-08-17Labeling · Supplement 5 · standard — Label ↗AP
2011-09-14Labeling · Supplement 3 · standard — Label ↗AP
2011-01-31Labeling · Supplement 4 · standard — Label ↗AP
2009-06-01Labeling · Supplement 2 · standard — Label ↗AP
2007-08-03Type 3 - New Dosage Form · Original · standard — Letter ↗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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