APPLICATION
ANDA212342
TYPE
ANDA
ORIGINAL APPROVAL
2020-11-24
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 3 · standardAP
2026-02-09Labeling · Supplement 6 · standardAP
2026-02-09Labeling · Supplement 7 · standardAP
2020-11-24UNKNOWN · 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.
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