← FDA DRUG APPROVALS

FDA NDA · NDA212268

SECUADO

asenapine

Sponsor: HISAMITSU

APPLICATION
NDA212268
TYPE
NDA
ORIGINAL APPROVAL
2019-10-11
LATEST ACTION
2025-01-22
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

SECUADO · ReferencePrescription
ASENAPINE 5.7MG/24HR · SYSTEM · TRANSDERMAL
SECUADO · ReferencePrescription
ASENAPINE 7.6MG/24HR · SYSTEM · TRANSDERMAL
SECUADO · ReferencePrescription
ASENAPINE 3.8MG/24HR · SYSTEM · TRANSDERMAL

Approval history

2025-01-22Labeling · Supplement 7 · standard — Label ↗AP
2019-10-11Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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