Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022117
Company: ALLERGAN
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 |
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 | 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 |