← FDA DRUG APPROVALS

FDA ANDA · ANDA091573

TROSPIUM CHLORIDE

Sponsor: PADAGIS US

APPLICATION
ANDA091573
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-17
LATEST ACTION
2013-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TROSPIUM CHLORIDEPrescription
TROSPIUM CHLORIDE 20MG · TABLET · ORAL

Approval history

2013-08-29Labeling · Supplement 3 · standardAP
2011-08-01Manufacturing (CMC) · Supplement 2AP
2011-03-31Labeling · Supplement 1AP
2010-11-17OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →