← FDA DRUG APPROVALS

FDA NDA · NDA020771

TOLTERODINE TARTRATE

Sponsor: UPJOHN

APPLICATION
NDA020771
TYPE
NDA
ORIGINAL APPROVAL
1998-03-25
LATEST ACTION
2014-07-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DETROL · ReferencePrescription
TOLTERODINE TARTRATE 1MG · TABLET · ORAL
DETROL · ReferencePrescription
TOLTERODINE TARTRATE 2MG · TABLET · ORAL

Approval history

2014-07-28Manufacturing (CMC) · Supplement 29 · standardAP
2012-08-01Labeling · Supplement 28 · standard — Letter ↗AP
2011-09-20Labeling · Supplement 24 · standard — Label ↗AP
2009-04-08Labeling · Supplement 22 · standard — Letter ↗AP
2008-09-11Labeling · Supplement 19 · standard — Label ↗AP
2007-03-16Labeling · Supplement 17 · standard — Letter ↗AP
2006-03-24Labeling · Supplement 14 · standard — Letter ↗AP
2005-10-17Labeling · Supplement 13 · standard — Label ↗AP
2004-01-05Labeling · Supplement 11 · standard — Review ↗AP
2003-07-21Labeling · Supplement 10 · standard — Letter ↗AP
2001-07-20Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
2001-04-06Efficacy · Supplement 4 · standard — Label ↗AP
2000-11-09Manufacturing (CMC) · Supplement 5 · standardAP
2000-10-24Labeling · Supplement 6 · standardAP
2000-05-26Manufacturing (CMC) · Supplement 3 · standardAP
1998-08-31Manufacturing (CMC) · Supplement 1 · standardAP
1998-03-25Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →