Application 212765

Type: ANDA
Sponsor: PIRAMAL HLTHCARE UK

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
A212765-001	EPLERENONE	EPLERENONE	25MG	TABLET / ORAL	AB		2020-08-10
A212765-002	EPLERENONE	EPLERENONE	50MG	TABLET / ORAL	AB		2020-08-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212765-001	AB
A212765-002	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 · 76 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	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212765-001	EPLERENONE	25MG	TABLET / ORAL	AB	2020-08-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212765-002	EPLERENONE	50MG	TABLET / ORAL	AB	2020-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212765-001	EPLERENONE	25MG	TABLET / ORAL		2020-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212765-002	EPLERENONE	50MG	TABLET / ORAL		2020-08-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A212765-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212765-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212765-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212765-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212765-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212765-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212765-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212765-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212765-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212765-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212765-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212765-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212765-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212765-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212765-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212765-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212765-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212765-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212765-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212765-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212765-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212765-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212765-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212765-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212765-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212765-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212765-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212765-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212765-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212765-002	AB	1	`8072bd15b7f6…`
2021-03-12 10:30 UTC	2021-03	A212765-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212765-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212765-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A212765-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212765-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A212765-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212765-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212765-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212765-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212765-002	AB	1	`1c564ffb4f44…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eplerenone	EPLERENONE	Bryant Ranch Prepack	bcd7595f-700f-48ba-bf83-05a995ce0731	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE
Eplerenone	EPLERENONE	Accord Healthcare, Inc.	b0886e4e-5710-4053-9270-4d7de34068e7	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE
EPLERENONE	EPLERENONE	Breckenridge Pharmaceutical, Inc.	e2a51c12-bdc2-4b3b-8e9e-bf363c2817ed	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: EPLERENONE generic name: EPLERENONE
Eplerenone	EPLERENONE	AvKARE	d953457e-0aff-6c38-e053-2995a90a7d32	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE
Eplerenone	EPLERENONE	Rising Pharma Holdings, Inc.	9b66a393-8af1-42bc-9673-89fe471147ee	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE
Inspra	EPLERENONE	Viatris Specialty LLC	1a52bedc-8e2c-4116-a296-a87770676b4a	2025-06-23	Warnings, Adverse reactions	Name fallback generic name: EPLERENONE
Eplerenone	EPLERENONE	Mylan Pharmaceuticals Inc.	4286699b-2320-4d3d-831c-32085f36fb67	2025-06-23	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE
EPLERENONE	EPLERENONE	American Health Packaging	3a3047f2-0155-4a07-955f-839a312cf879	2025-05-19	Warnings, Adverse reactions	Name fallback brand name: EPLERENONE generic name: EPLERENONE
Eplerenone	EPLERENONE	Bryant Ranch Prepack	2002cf90-2d4a-43b1-bcd6-c447cbc7010f	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE
EPLERENONE	EPLERENONE	Camber Pharmaceuticals, Inc.	25a1c77c-7008-4b07-af14-5522a282783a	2023-06-15	Warnings, Adverse reactions	Name fallback brand name: EPLERENONE generic name: EPLERENONE
Eplerenone	EPLERENONE	Proficient Rx LP	49b9759a-c1b9-4ebe-874b-81fb82a42755	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE
Eplerenone	EPLERENONE	Westminster Pharmaceuticals, LLC	316d3a98-4cd1-4499-a34c-cac87e016944	2021-11-15	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE
Eplerenone	EPLERENONE	Mylan Pharmaceuticals Inc.	6d988699-95c2-46b9-8266-23fe7016f33b	2020-08-27	Warnings, Adverse reactions	Name fallback brand name: Eplerenone generic name: EPLERENONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70436-098	eplerenone	eplerenone	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-099	eplerenone	eplerenone	Slate Run Pharmaceuticals, LLC	ANDA	Current