APPLICATION
NDA017874
TYPE
NDA
ORIGINAL APPROVAL
1979-12-31
LATEST ACTION
2025-06-10
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription
Products
TRANSDERM SCOP · ReferencePrescription
SCOPOLAMINE 1MG/72HR · SYSTEM · TRANSDERMAL
Approval history
2017-09-13Labeling · Supplement 41 · standardAP
2013-05-15Manufacturing (CMC) · Supplement 40 · standardAP
2000-05-30Manufacturing (CMC) · Supplement 30 · standardAP
1998-06-19Manufacturing (CMC) · Supplement 29 · standardAP
1996-10-07Manufacturing (CMC) · Supplement 28 · standardAP
1994-05-31Manufacturing (CMC) · Supplement 26 · standardAP
1993-06-28Manufacturing (CMC) · Supplement 24 · standardAP
1993-02-10Manufacturing (CMC) · Supplement 25 · standardAP
1992-03-05Manufacturing (CMC) · Supplement 23 · standardAP
1990-07-10Manufacturing (CMC) · Supplement 22 · standardAP
1988-10-03Manufacturing (CMC) · Supplement 17 · standardAP
1988-03-17Manufacturing (CMC) · Supplement 16 · standardAP
1984-07-25Manufacturing (CMC) · Supplement 14 · standardAP
1982-06-02Manufacturing (CMC) · Supplement 13 · standardAP
1981-11-02Manufacturing (CMC) · Supplement 11 · standardAP
1981-10-27Labeling · Supplement 9AP
1981-04-10Manufacturing (CMC) · Supplement 5 · standardAP
1981-02-09Manufacturing (CMC) · Supplement 6 · standardAP
1980-01-28Manufacturing (CMC) · Supplement 1 · standardAP
1979-12-31Type 3 - New Dosage Form · 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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