← FDA DRUG APPROVALS

FDA NDA · NDA022117

SAPHRIS

asenapine maleate

Sponsor: ABBVIE

APPLICATION
NDA022117
TYPE
NDA
ORIGINAL APPROVAL
2009-08-13
LATEST ACTION
2025-01-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SAPHRIS · ReferencePrescription
ASENAPINE MALEATE EQ 5MG BASE · TABLET · SUBLINGUAL
SAPHRIS · ReferencePrescription
ASENAPINE MALEATE EQ 10MG BASE · TABLET · SUBLINGUAL
SAPHRIS · ReferencePrescription
ASENAPINE MALEATE EQ 2.5MG BASE · TABLET · SUBLINGUAL

Approval history

2025-01-22Labeling · Supplement 24 · standard — Label ↗AP
2017-02-23Labeling · Supplement 22 · 901 required — Label ↗AP
2017-01-13Efficacy · Supplement 20 · standard — Label ↗AP
2017-01-13Efficacy · Supplement 21 · standard — Label ↗AP
2015-03-12Efficacy · Supplement 18 · priority — Pediatric Written Request ↗AP
2015-03-12Efficacy · Supplement 19 · priority — Pediatric Written Request ↗AP
2015-03-12Labeling · Supplement 17 · standard — Label ↗AP
2014-11-18Labeling · Supplement 16 · standard — Label ↗AP
2014-11-18Labeling · Supplement 14 · standard — Label ↗AP
2014-11-18Labeling · Supplement 15 · standard — Letter ↗AP
2014-10-21Labeling · Supplement 11 · standard — Letter ↗AP
2013-03-21Labeling · Supplement 12 · standard — Label ↗AP
2012-11-08Labeling · Supplement 13 · standard — Label ↗AP
2011-10-11Labeling · Supplement 9 · standard — Label ↗AP
2011-08-09Labeling · Supplement 10 · 901 required — Label ↗AP
2010-12-01Labeling · Supplement 7 · 901 required — Letter ↗AP
2010-09-03Efficacy · Supplement 3 · standard — Letter ↗AP
2010-09-03Efficacy · Supplement 4 · standard — Label ↗AP
2009-08-13Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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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