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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022117
Company: ALLERGAN

Other Important Information from FDA

Summary Review

Products on NDA 022117

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAPHRIS	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	AB	Yes	No
SAPHRIS	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	AB	Yes	Yes
SAPHRIS	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET;SUBLINGUAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/13/2009	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022117s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022117s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022117s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2017	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022117Orig1s022ltr.pdf
01/13/2017	SUPPL-21	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022117Orig1s020,022117Orig1s021ltr.pdf
01/13/2017	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022117Orig1s020,022117Orig1s021ltr.pdf
03/12/2015	SUPPL-19	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf
03/12/2015	SUPPL-18	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf
03/12/2015	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf
11/18/2014	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf
11/18/2014	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf
11/18/2014	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf
11/08/2012	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022117s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022117Orig1s013ltr.pdf
03/21/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022117s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022117Orig1s012ltr.pdf
10/21/2014	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s011ltr.pdf
08/09/2011	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022117s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022117s010ltr.pdf
10/11/2011	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022117s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022117s009ltr.pdf
12/01/2010	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s007ltr.pdf
09/03/2010	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s003s004ltr.pdf
09/03/2010	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s003s004ltr.pdf

Labels for NDA 022117

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2017	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s022lbl.pdf
01/13/2017	SUPPL-21	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s020s021lbl.pdf
01/13/2017	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s020s021lbl.pdf
03/12/2015	SUPPL-19	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf
03/12/2015	SUPPL-18	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf
03/12/2015	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022117s017s018s019lbl.pdf
11/18/2014	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf
11/18/2014	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf
11/18/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s014s015s016lbl.pdf
10/21/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022117s011lbl.pdf
03/21/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022117s012lbl.pdf
11/08/2012	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022117s013lbl.pdf
10/11/2011	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022117s009lbl.pdf
08/09/2011	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022117s010lbl.pdf
12/01/2010	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s007lbl.pdf
09/03/2010	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf
09/03/2010	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf
08/13/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022117s000lbl.pdf

Therapeutic Equivalents for NDA 022117

SAPHRIS

TABLET;SUBLINGUAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206098	ALEMBIC
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	205960	BRECKENRIDGE
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206107	SIGMAPHARM LABS LLC
SAPHRIS	ASENAPINE MALEATE	EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription	Yes	AB	022117	ALLERGAN

TABLET;SUBLINGUAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206098	ALEMBIC
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	205960	BRECKENRIDGE
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206107	SIGMAPHARM LABS LLC
SAPHRIS	ASENAPINE MALEATE	EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription	Yes	AB	022117	ALLERGAN

TABLET;SUBLINGUAL; EQ 2.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	206098	ALEMBIC
ASENAPINE MALEATE	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET;SUBLINGUAL	Prescription	No	AB	205960	BRECKENRIDGE
SAPHRIS	ASENAPINE MALEATE	EQ 2.5MG BASE	TABLET;SUBLINGUAL	Prescription	Yes	AB	022117	ALLERGAN

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