FDA.reportPublic FDA data

Application 021437

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INSPRAEPLERENONETABLET;ORAL25MGYesNo
002INSPRAEPLERENONETABLET;ORAL50MGYesYes
003INSPRAEPLERENONETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1710InspraeplerenoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1710InspraeplerenoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1710InspraeplerenonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1710InspraeplerenonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1710InspraeplerenoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1720InspraeplerenonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1720InspraeplerenonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1720InspraeplerenoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1720InspraeplerenoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1720InspraeplerenoneG.D. Searle LLC Division of Pfizer IncNDACurrent
21695-797InspraeplerenoneRebel Distributors CorpNDACurrent
59762-1710EplerenoneeplerenoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1710EplerenoneeplerenoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1710EplerenoneeplerenoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1720EplerenoneeplerenoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1720EplerenoneeplerenoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1720EplerenoneeplerenoneGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82592SUPPL 2025-06-17
82588SUPPL 2025-06-17
54393SUPPL2018-05-31
54384SUPPL2018-05-31
36928SUPPL2016-05-05
5377SUPPL2016-05-05
27782SUPPL2013-05-21
15471SUPPL2013-05-21
15469SUPPL2012-07-13
5375SUPPL2012-07-13
15470SUPPL2012-06-26
5376SUPPL2012-06-26
15468SUPPL2008-05-19
27781SUPPL2008-05-09
5374SUPPL2008-02-04
36927SUPPL2008-01-31
52936SUPPL2007-10-19
52935SUPPL2007-10-19
52934SUPPL2007-10-19
51717SUPPL2007-10-19
51716SUPPL2006-06-07
51715SUPPL2004-10-01
21658SUPPL2004-09-09
51713SUPPL2004-08-17
42165ORIG2004-06-07
15467SUPPL2003-10-10
5373SUPPL2003-10-07
51714SUPPL2003-03-21
36926ORIG2002-09-27
5372ORIG2002-09-27