APPLICATION
ANDA091575
TYPE
ANDA
ORIGINAL APPROVAL
2010-08-13
LATEST ACTION
2025-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TROSPIUM CHLORIDEPrescription
TROSPIUM CHLORIDE 20MG · TABLET · ORAL
Approval history
2025-04-04Labeling · Supplement 11 · standardAP
2013-12-31Labeling · Supplement 8 · standardAP
2013-07-31Labeling · Supplement 7 · standardAP
2012-11-30Labeling · Supplement 5 · standardAP
2012-05-31Labeling · Supplement 3AP
2011-03-31Labeling · Supplement 1AP
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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