Application 021437

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021437-001INSPRAEPLERENONE25MGTABLET / ORALABRLD2002-09-27
N021437-002INSPRAEPLERENONE50MGTABLET / ORALABRLD, RS2002-09-27
N021437-003INSPRAEPLERENONE100MGTABLET / ORAL2002-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021437-001AB
N021437-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021437-003INSPRA100MGTABLET / ORAL2002-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-003INSPRA100MGTABLET / ORAL2002-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021437-003INSPRA100MGTABLET / ORAL2002-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-003INSPRA100MGTABLET / ORAL2002-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-003INSPRA100MGTABLET / ORAL2002-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-003INSPRA100MGTABLET / ORAL2002-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-003INSPRA100MGTABLET / ORAL2002-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-003INSPRA100MGTABLET / ORAL2002-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-003INSPRA100MGTABLET / ORAL2002-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N021437-003INSPRA100MGTABLET / ORAL2002-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-003INSPRA100MGTABLET / ORAL2002-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-003INSPRA100MGTABLET / ORAL2002-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021437-002INSPRA50MGTABLET / ORALABRLD, RS2002-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021437-003INSPRA100MGTABLET / ORAL2002-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021437-001INSPRA25MGTABLET / ORALABRLD2002-09-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021437-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021437-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021437-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021437-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021437-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021437-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021437-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021437-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021437-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021437-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021437-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021437-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021437-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021437-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021437-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021437-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021437-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021437-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021437-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021437-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021437-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021437-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021437-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021437-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021437-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021437-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021437-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021437-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021437-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021437-002AB1782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021437-00164105242019-11-05U-46774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00167470202019-11-05U-58774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00164100542019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00164100542019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00164951652019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00164951652019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00165340932019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00165340932019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00165587072019-12-08U-537Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00171571012019-12-08U-664Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016410524*PED2020-05-05Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016747020*PED2020-05-05Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016410054*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016495165*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016534093*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0016558707*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0017157101*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264105242019-11-05U-46774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00267470202019-11-05U-58774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264100542019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264100542019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264951652019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00264951652019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00265340932019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00265340932019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00265587072019-12-08U-537Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00271571012019-12-08U-664Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026410524*PED2020-05-05Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026747020*PED2020-05-05Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026410054*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026495165*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026534093*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0026558707*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-0027157101*PED2020-06-08Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364105242019-11-05U-46774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00367470202019-11-05U-58774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364100542019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364100542019-12-08U-53774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364951652019-12-08U-374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021437-00364951652019-12-08U-53774a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InspraEPLERENONEViatris Specialty LLC1a52bedc-8e2c-4116-a296-a87770676b4a2025-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021437
application number: NDA021437
EplerenoneEPLERENONEMylan Pharmaceuticals Inc.4286699b-2320-4d3d-831c-32085f36fb672025-06-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021437
application number: NDA021437
EplerenoneEPLERENONEMylan Pharmaceuticals Inc.6d988699-95c2-46b9-8266-23fe7016f33b2020-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 021437
application number: NDA021437
ndc (product): 59762-1720
ndc (product): 59762-1710

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

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
0025-1710InspraeplerenoneG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1710InspraeplerenonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1710InspraeplerenonePfizer 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
0025-1720InspraeplerenonePfizer Laboratories Div Pfizer IncNDACurrent
0025-1720InspraeplerenonePfizer Laboratories Div 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