FDA.reportPublic FDA data

Application 022256

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAVELLAMILNACIPRAN HYDROCHLORIDETABLET;ORAL12.5MGYesNo
002SAVELLAMILNACIPRAN HYDROCHLORIDETABLET;ORAL25MGYesNo
003SAVELLAMILNACIPRAN HYDROCHLORIDETABLET;ORAL50MGYesYes
004SAVELLAMILNACIPRAN HYDROCHLORIDETABLET;ORAL100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-1500Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1500Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1500Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1500Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1500Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1510Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1510Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1510Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1510Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1510Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1512Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1512Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1512Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1512Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1512Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1525Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1525Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1525Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1525Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1525Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1550Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1550Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1550Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1550Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
0456-1550Savellamilnacipran hydrochlorideAllergan, Inc.NDACurrent
21695-650Savellamilnacipran hydrochlorideRebel Distributors CorpNDACurrent
21695-651Savellamilnacipran hydrochlorideRebel Distributors CorpNDACurrent
35356-545Savellamilnacipran hydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
50436-9993Savellamilnacipran hydrochlorideUnit Dose ServicesNDACurrent
55154-4626Savellamilnacipran hydrochlorideCardinal HealthNDACurrent
55154-4626Savellamilnacipran hydrochlorideCardinal HealthNDACurrent
55154-4626Savellamilnacipran hydrochlorideCardinal Health 107, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83340SUPPL 2025-09-11
83339SUPPL 2025-09-11
83326SUPPL 2025-09-11
79029SUPPL 2024-07-09
79028SUPPL 2024-07-09
75263SUPPL 2023-08-22
75144SUPPL 2023-08-21
73634SUPPL 2023-03-01
73633SUPPL 2023-03-01
68717SUPPL2021-09-22
68684SUPPL2021-09-21
68683SUPPL2021-09-21
50869SUPPL2017-12-27
50816SUPPL2017-12-21
50815SUPPL2017-12-21
46667SUPPL2017-01-05
46651SUPPL2017-01-03
45246SUPPL2016-09-06
45239SUPPL2016-09-06
29483SUPPL2015-02-02
17159SUPPL2015-01-30
38454SUPPL2013-10-31
38453SUPPL2013-10-31
29482SUPPL2013-10-31
7124SUPPL2013-10-31
42470SUPPL2013-08-06
38455SUPPL2013-06-26
29481SUPPL2012-12-11
38452SUPPL2012-12-07
29480SUPPL2012-11-08
29479SUPPL2011-11-10
17158SUPPL2011-11-09
7123SUPPL2011-05-03
29478SUPPL2010-05-21
38451SUPPL2010-05-18
17156SUPPL2010-02-23
17157SUPPL2010-02-16
7122SUPPL2010-02-16
7121SUPPL2010-02-16
38450SUPPL2009-04-23
7120SUPPL2009-04-21
42469ORIG2009-03-24
44718ORIG2009-01-15
17155ORIG2009-01-14
7119ORIG2009-01-14