APPLICATION
ANDA078830
TYPE
ANDA
ORIGINAL APPROVAL
2015-01-30
LATEST ACTION
2026-02-09
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription
Products
SCOPOLAMINEPrescription
SCOPOLAMINE 1MG/72HR · SYSTEM · TRANSDERMAL
Approval history
2026-02-09Labeling · Supplement 21 · standardAP
2026-02-09Labeling · Supplement 16 · standardAP
2023-10-27Labeling · Supplement 11 · 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.