Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022117
Company: ALLERGAN
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
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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