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FDA NDA · NDA021228

DETROL LA

Sponsor: UPJOHN

APPLICATION
NDA021228
TYPE
NDA
ORIGINAL APPROVAL
2000-12-22
LATEST ACTION
2018-07-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DETROL LA · ReferencePrescription
TOLTERODINE TARTRATE 2MG · CAPSULE, EXTENDED RELEASE · ORAL
DETROL LA · ReferencePrescription
TOLTERODINE TARTRATE 4MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2018-07-13Labeling · Supplement 23 · standard — Label ↗AP
2014-07-28Manufacturing (CMC) · Supplement 22 · standardAP
2012-08-01Labeling · Supplement 21 · standard — Letter ↗AP
2011-09-20Labeling · Supplement 16 · standard — Letter ↗AP
2010-01-05Labeling · Supplement 15 · standard — Letter ↗AP
2008-09-11Labeling · Supplement 12 · standard — Letter ↗AP
2007-03-16Labeling · Supplement 10 · standard — Letter ↗AP
2005-10-20Efficacy · Supplement 7 · unknown — Letter ↗AP
2005-07-14Labeling · Supplement 8 · standard — Label ↗AP
2004-04-14Efficacy · Supplement 6 · priority — Review ↗AP
2004-01-15Labeling · Supplement 5 · standard — Letter ↗AP
2003-07-21Labeling · Supplement 4 · standard — Letter ↗AP
2001-12-17Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
2001-09-21Labeling · Supplement 2 · standard — Review ↗AP
2001-04-27Labeling · Supplement 1 · standard — Review ↗AP
2000-12-22Type 3 - New Dosage Form · Original · standard — Label ↗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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