APPLICATION
ANDA216297
TYPE
ANDA
ORIGINAL APPROVAL
2024-10-07
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
GLYCOPYRROLATEPrescription
GLYCOPYRROLATE 1MG/5ML · SOLUTION · ORAL
Approval history
2025-06-13Labeling · Supplement 1 · standardAP
2024-10-07UNKNOWN · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.