Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022117
Company: FOREST LABS LLC
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 2.5 BASE TABLET;SUBLINGUAL Prescription None Yes No
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
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

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 206107 SIGMAPHARM LABS LLC
SAPHRIS ASENAPINE MALEATE EQ 5MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022117 FOREST LABS LLC

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 206107 SIGMAPHARM LABS LLC
SAPHRIS ASENAPINE MALEATE EQ 10MG BASE TABLET;SUBLINGUAL Prescription Yes AB 022117 FOREST LABS LLC

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