FDA.reportPublic FDA data

Application 022117

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAPHRISASENAPINE MALEATETABLET;SUBLINGUALEQ 5MG BASEYesNo
002SAPHRISASENAPINE MALEATETABLET;SUBLINGUALEQ 10MG BASEYesYes
003SAPHRISASENAPINE MALEATETABLET;SUBLINGUALEQ 2.5MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0052-0118SAPHRISAsenapine MaleateOrganon Pharmaceuticals USANDACurrent
0052-0119SAPHRISAsenapine MaleateOrganon Pharmaceuticals USANDACurrent
0052-2139SAPHRISAsenapine MaleateOrganon Pharmaceuticals USANDACurrent
0052-2142SAPHRISAsenapine MaleateOrganon Pharmaceuticals USANDACurrent
0456-2402SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2402SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2402SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2402SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2405SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2405SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2405SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2405SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2410SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2410SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2410SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
0456-2410SAPHRISAsenapine MaleateAllergan, Inc.NDACurrent
59762-1091Asenapineasenapine maleateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1091Asenapineasenapine maleateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2012Asenapineasenapine maleateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2012Asenapineasenapine maleateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2888Asenapineasenapine maleateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2888Asenapineasenapine maleateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81115SUPPL 2025-02-06
80947SUPPL 2025-02-05
47405SUPPL2017-03-02
47309SUPPL2017-02-24
46941SUPPL2017-01-24
46940SUPPL2017-01-24
46859SUPPL2017-01-13
46858SUPPL2017-01-13
38282SUPPL2015-03-17
38281SUPPL2015-03-17
16985SUPPL2015-03-17
29288SUPPL2015-03-13
29287SUPPL2015-03-13
6933SUPPL2015-03-13
38280SUPPL2014-11-20
16984SUPPL2014-11-20
16983SUPPL2014-11-20
29286SUPPL2014-11-19
29285SUPPL2014-11-19
6932SUPPL2014-11-19
16980SUPPL2014-10-24
6931SUPPL2014-10-23
51247SUPPL2014-02-06
51246SUPPL2014-02-06
51245SUPPL2013-08-30
51244SUPPL2013-08-30
16981SUPPL2013-03-26
29283SUPPL2013-03-22
29284SUPPL2012-11-09
16982SUPPL2012-11-08
44172ORIG2011-12-20
29282SUPPL2011-10-13
38278SUPPL2011-10-12
38279SUPPL2011-08-11
6930SUPPL2011-08-11
6929SUPPL2010-12-07
16979SUPPL2010-12-04
51243SUPPL2010-10-22
51242SUPPL2010-10-22
29281SUPPL2010-09-21
6928SUPPL2010-09-21
38277SUPPL2010-08-30
16978SUPPL2010-08-30
51241SUPPL2010-06-02
51240SUPPL2010-06-02
24244ORIG2009-10-02
21939ORIG2009-10-02
51239SUPPL2009-09-23
51238SUPPL2009-09-23
16977ORIG2009-08-26
6927ORIG2009-08-26
51735SUPPL1900-01-01
51733SUPPL1900-01-01
51732SUPPL1900-01-01
51731SUPPL1900-01-01
51727SUPPL1900-01-01
51726SUPPL1900-01-01