FDA.reportPublic FDA data

Application 012151

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
008ALDACTONESPIRONOLACTONETABLET;ORAL50MGYesNo
009ALDACTONESPIRONOLACTONETABLET;ORAL25MGYesNo
010ALDACTONESPIRONOLACTONETABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1001AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1001AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1001AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1001AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1001AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1001AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1031AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1031AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1031AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1031AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1031AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1031AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1041AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1041AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1041AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1041AldactonespironolactoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1041AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1041AldactonespironolactonePfizer Laboratories Div Pfizer IncNDACurrent
59762-5011spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5011spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5011spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5011spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5012spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5012spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5012spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5012spironolactonespironolactoneGreenstone LLCNDA AUTHORIZED GENERICCurrent
70518-1396AldactonespironolactoneREMEDYREPACK INC.NDACurrent
70518-1396AldactonespironolactoneREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84179SUPPL 2025-11-18
84177SUPPL 2025-11-17
72971SUPPL2022-12-21
72969SUPPL2022-12-21
64145SUPPL2020-07-30
64117SUPPL2020-07-29
52909SUPPL2018-03-12
52875SUPPL2018-03-08
10797SUPPL2014-10-24
10796SUPPL2013-06-18
309SUPPL2013-06-13
308SUPPL2012-09-20
33076SUPPL2012-09-17
11992SUPPL2011-09-26
10795SUPPL2009-01-02
11991SUPPL2008-11-26