APPLICATION
ANDA217893
TYPE
ANDA
ORIGINAL APPROVAL
2024-08-29
LATEST ACTION
2025-08-20
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription
Products
SCOPOLAMINEPrescription
SCOPOLAMINE 1MG/72HR · SYSTEM · TRANSDERMAL
Approval history
2025-08-20Labeling · Supplement 1 · standardAP
2024-08-29UNKNOWN · 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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