Application 215341

Type: NDA
Sponsor: BAYER HEALTHCARE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KERENDIA	FINERENONE	TABLET; ORAL	10MG	No	No
002	KERENDIA	FINERENONE	TABLET; ORAL	20MG	No	No
003	KERENDIA	FINERENONE	TABLET;ORAL	40MG	Yes	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215341-001	KERENDIA	FINERENONE	10MG	TABLET / ORAL	RLD	2021-07-09
N215341-002	KERENDIA	FINERENONE	20MG	TABLET / ORAL	RLD	2021-07-09
N215341-003	KERENDIA	FINERENONE	40MG	TABLET / ORAL	RLD, RS	2025-07-11

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06
N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01
N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06
N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01
N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25
N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215341-001	NCE	2026-07-09
N215341-001	I-970	2028-07-11
N215341-002	NCE	2026-07-09
N215341-002	I-970	2028-07-11
N215341-003	NCE	2026-07-09
N215341-003	NS	2028-07-11

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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	KERENDIA	40MG	TABLET / ORAL	RLD	2025-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	KERENDIA	40MG	TABLET / ORAL	RLD	2025-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	KERENDIA	40MG	TABLET / ORAL	RLD	2025-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N215341-002	KERENDIA	20MG	TABLET / ORAL	RLD, RS	2021-07-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215341-001	KERENDIA	10MG	TABLET / ORAL	RLD	2021-07-09	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215341-001	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	8436180	2033-08-26	Drug substance, Drug product	2021-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	8436180	2033-08-26	Drug substance, Drug product	2025-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	8436180	2029-04-12	Drug substance, Drug product	2025-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	8436180	2029-04-12	Drug substance, Drug product	2025-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	RE49826	2035-07-29	Drug substance	2025-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-002	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-002	RE49826	2035-07-29	Drug substance	2024-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215341-001	8436180	2029-04-12	Drug substance, Drug product	2021-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215341-001	RE49826	2035-07-29	Drug substance	2024-03-01	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215341-001	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-001	I-970	2028-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-002	I-970	2028-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	NCE	2026-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215341-003	NS	2028-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	M-279	2025-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-001	I-970	2028-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	M-279	2025-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-002	I-970	2028-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	NCE	2026-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215341-003	NS	2028-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215341-001	M-279	2025-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-001	NCE	2026-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-001	I-970	2028-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	M-279	2025-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	NCE	2026-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-002	I-970	2028-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	NCE	2026-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215341-003	NS	2028-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	M-279	2025-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-001	NCE	2026-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	M-279	2025-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215341-002	NCE	2026-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-001	M-279	2025-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-001	NCE	2026-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-002	M-279	2025-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215341-002	NCE	2026-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-001	M-279	2025-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-001	NCE	2026-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-002	M-279	2025-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215341-002	NCE	2026-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-001	M-279	2025-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-001	NCE	2026-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-002	M-279	2025-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215341-002	NCE	2026-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-001	M-279	2025-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215341-001	NCE	2026-07-09	`5bbf6a4d5a75…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kerendia	FINERENONE	Bayer HealthCare Pharmaceuticals Inc.	fc726765-5d5a-4d6e-b037-b847bda9fb7c	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215341 application number: NDA215341 ndc (product): 50419-540 ndc (product): 50419-541

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-540	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current
50419-541	Kerendia	finerenone	Bayer Healthcare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82856	SUPPL	2026-05-12
82867	SUPPL	2025-07-15
72002	SUPPL	2022-09-02
71995	SUPPL	2022-09-02
68296	ORIG	2021-08-05
68048	ORIG	2021-07-12
68045	ORIG	2021-07-12