APPLICATION
ANDA040847
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-21
LATEST ACTION
2026-01-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GLYCOPYRROLATEPrescription
GLYCOPYRROLATE 2MG · TABLET · ORAL
GLYCOPYRROLATEPrescription
GLYCOPYRROLATE 1MG · TABLET · ORAL
Approval history
2026-01-19Labeling · Supplement 5 · standardAP
2012-12-06Labeling · Supplement 1 · standardAP
2008-03-21OriginalAP
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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