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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 22117

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

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

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