Saphris

NDA 22117, held by Abbvie. Asenapine Maleate.

As of Nov 13, 2026, NDA 22117 (Saphris), held by Abbvie, was first approved by FDA on Aug 13, 2009, with 18 approved supplements and 0 published complete response letters.

First approved: Aug 13, 2009
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1 INDICATIONS AN D USAGE SAPHRIS is indicated for: Schizophrenia in adults Bipolar I disorder

Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jan 13, 2017	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 13, 2017	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 12, 2015	Supplement 19Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Amendment 4 Pediatric Amendment 3
Mar 12, 2015	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Amendment 4 Pediatric Amendment 3
Sep 3, 2010	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 3, 2010	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 13, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms


SaphrisEQ 5MG BASE · tablet;sublingual	Asenapine Maleate	RxReference drug
SaphrisEQ 10MG BASE · tablet;sublingual	Asenapine Maleate	RxReference drug
SaphrisEQ 2.5MG BASE · tablet;sublingual	Asenapine Maleate	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 24Labeling · Standard review	Approved	Letter Label
Feb 23, 2017	Supplement 22Labeling	Approved	Letter Label
Jan 13, 2017	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 13, 2017	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 12, 2015	Supplement 19Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Amendment 4 Pediatric Amendment 3
Mar 12, 2015	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Amendment 4 Pediatric Amendment 3
Mar 12, 2015	Supplement 17Labeling · Standard review	Approved	Label Letter
Nov 18, 2014	Supplement 16Labeling · Standard review	Approved	Label Letter
Nov 18, 2014	Supplement 15Labeling · Standard review	Approved	Label Letter
Nov 18, 2014	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 21, 2014	Supplement 11Labeling · Standard review	Approved	Label Letter
Mar 21, 2013	Supplement 12Labeling · Standard review	Approved	Label Letter
Nov 8, 2012	Supplement 13Labeling · Standard review	Approved	Letter Label
Oct 11, 2011	Supplement 9Labeling · Standard review	Approved	Letter Label
Aug 9, 2011	Supplement 10Labeling	Approved	Letter Label
Dec 1, 2010	Supplement 7Labeling	Approved	Letter Label
Sep 3, 2010	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 3, 2010	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 13, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22117
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters