Application 021437

Type: NDA
Sponsor: GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INSPRA	EPLERENONE	TABLET;ORAL	25MG	Yes	No
002	INSPRA	EPLERENONE	TABLET;ORAL	50MG	Yes	Yes
003	INSPRA	EPLERENONE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021437-001	INSPRA	EPLERENONE	25MG	TABLET / ORAL	AB	RLD	2002-09-27
N021437-002	INSPRA	EPLERENONE	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27
N021437-003	INSPRA	EPLERENONE	100MG	TABLET / ORAL			2002-09-27

Therapeutic equivalence codes#

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

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

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021437-002	INSPRA	50MG	TABLET / ORAL	AB	RLD, RS	2002-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021437-003	INSPRA	100MG	TABLET / ORAL			2002-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021437-001	INSPRA	25MG	TABLET / ORAL	AB	RLD	2002-09-27	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021437-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021437-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021437-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021437-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021437-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021437-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021437-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021437-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021437-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021437-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021437-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021437-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021437-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021437-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021437-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021437-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021437-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021437-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021437-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021437-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021437-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021437-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021437-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021437-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021437-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021437-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021437-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021437-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021437-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021437-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021437-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021437-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021437-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021437-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021437-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021437-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021437-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021437-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021437-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021437-002	AB	1	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 2 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021437-003	6534093	2019-12-08	U-3		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	6534093	2019-12-08	U-537		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	6558707	2019-12-08	U-537	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	7157101	2019-12-08	U-664	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	6410524*PED	2020-05-05		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	6747020*PED	2020-05-05		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	6410054*PED	2020-06-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	6495165*PED	2020-06-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	6534093*PED	2020-06-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	6558707*PED	2020-06-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021437-003	7157101*PED	2020-06-08		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021437-001	6410524*PED	2020-05-05		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-001	6747020*PED	2020-05-05		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-001	6410054*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-001	6495165*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-001	6534093*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-001	6558707*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-001	7157101*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-002	6410524*PED	2020-05-05		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-002	6747020*PED	2020-05-05		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-002	6410054*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-002	6495165*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-002	6534093*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-002	6558707*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-002	7157101*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-003	6410524*PED	2020-05-05		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-003	6747020*PED	2020-05-05		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-003	6410054*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-003	6495165*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-003	6534093*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-003	6558707*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021437-003	7157101*PED	2020-06-08		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021437-001	6410524*PED	2020-05-05		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021437-001	6747020*PED	2020-05-05		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021437-001	6410054*PED	2020-06-08		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021437-001	6495165*PED	2020-06-08		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021437-001	6534093*PED	2020-06-08		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021437-001	6558707*PED	2020-06-08		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021437-001	7157101*PED	2020-06-08		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021437-002	6410524*PED	2020-05-05		Pediatric extension	`c0c555d07b60…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Inspra	EPLERENONE	Viatris Specialty LLC	1a52bedc-8e2c-4116-a296-a87770676b4a	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021437 application number: NDA021437
Eplerenone	EPLERENONE	Mylan Pharmaceuticals Inc.	4286699b-2320-4d3d-831c-32085f36fb67	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021437 application number: NDA021437

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-1710	Inspra	eplerenone	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1710	Inspra	eplerenone	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1710	Inspra	eplerenone	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1710	Inspra	eplerenone	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1710	Inspra	eplerenone	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1720	Inspra	eplerenone	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1720	Inspra	eplerenone	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1720	Inspra	eplerenone	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1720	Inspra	eplerenone	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1720	Inspra	eplerenone	Pfizer Laboratories Div Pfizer Inc	NDA	Current
21695-797	Inspra	eplerenone	Rebel Distributors Corp	NDA	Current
59762-1710	Eplerenone	eplerenone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1710	Eplerenone	eplerenone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1710	Eplerenone	eplerenone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1720	Eplerenone	eplerenone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1720	Eplerenone	eplerenone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1720	Eplerenone	eplerenone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82592	SUPPL	2025-06-17
82588	SUPPL	2025-06-17
54393	SUPPL	2018-05-31
54384	SUPPL	2018-05-31
36928	SUPPL	2016-05-05
5377	SUPPL	2016-05-05
27782	SUPPL	2013-05-21
15471	SUPPL	2013-05-21
15469	SUPPL	2012-07-13
5375	SUPPL	2012-07-13
15470	SUPPL	2012-06-26
5376	SUPPL	2012-06-26
15468	SUPPL	2008-05-19
27781	SUPPL	2008-05-09
5374	SUPPL	2008-02-04
36927	SUPPL	2008-01-31
52936	SUPPL	2007-10-19
52935	SUPPL	2007-10-19
52934	SUPPL	2007-10-19
51717	SUPPL	2007-10-19
51716	SUPPL	2006-06-07
51715	SUPPL	2004-10-01
21658	SUPPL	2004-09-09
51713	SUPPL	2004-08-17
42165	ORIG	2004-06-07
15467	SUPPL	2003-10-10
5373	SUPPL	2003-10-07
51714	SUPPL	2003-03-21
36926	ORIG	2002-09-27
5372	ORIG	2002-09-27