Application 207842

Type: ANDA
Sponsor: REGCON SOLUTIONS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207842-001	EPLERENONE	EPLERENONE	25MG	TABLET / ORAL	AB		2021-10-25
A207842-002	EPLERENONE	EPLERENONE	50MG	TABLET / ORAL	AB		2021-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207842-001	AB
A207842-002	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 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207842-001	EPLERENONE	25MG	TABLET / ORAL	AB	2021-10-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207842-002	EPLERENONE	50MG	TABLET / ORAL	AB	2021-10-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207842-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207842-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207842-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207842-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207842-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207842-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207842-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207842-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207842-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207842-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207842-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207842-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207842-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207842-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207842-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207842-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207842-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207842-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207842-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207842-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207842-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207842-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207842-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207842-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207842-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207842-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207842-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207842-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207842-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207842-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207842-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207842-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207842-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207842-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207842-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207842-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207842-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207842-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207842-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207842-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eplerenone	EPLERENONE	AvKARE	d953457e-0aff-6c38-e053-2995a90a7d32	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207842 application number: ANDA207842 ndc (product): 42291-455 ndc (product): 42291-454
Eplerenone	EPLERENONE	Bryant Ranch Prepack	2002cf90-2d4a-43b1-bcd6-c447cbc7010f	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207842 application number: ANDA207842
Eplerenone	EPLERENONE	Proficient Rx LP	49b9759a-c1b9-4ebe-874b-81fb82a42755	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207842 application number: ANDA207842 ndc (product): 71205-863 ndc (product): 71205-864
Eplerenone	EPLERENONE	Westminster Pharmaceuticals, LLC	316d3a98-4cd1-4499-a34c-cac87e016944	2021-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207842 application number: ANDA207842 ndc (product): 69367-307 ndc (product): 69367-308

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-454	Eplerenone	Eplerenone	AvKARE	ANDA	Current
42291-454	Eplerenone	Eplerenone	AvKARE	ANDA	Current
42291-455	Eplerenone	Eplerenone	AvKARE	ANDA	Current
42291-455	Eplerenone	Eplerenone	AvKARE	ANDA	Current
69367-307	Eplerenone	Eplerenone	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-308	Eplerenone	Eplerenone	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-863	Eplerenone	Eplerenone	Proficient Rx LP	ANDA	Current
71205-864	Eplerenone	Eplerenone	Proficient Rx LP	ANDA	Current