Application 214916

Type: NDA
Sponsor: CARA THERAPEUTICS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KORSUVA	DIFELIKEFALIN	SOLUTION;INTRAVENOUS	65MCG/1.3ML (50MCG/ML)	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214916-001	KORSUVA	DIFELIKEFALIN ACETATE	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-08-23

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214916-001	10017536	2027-11-12	U-3204	Drug substance	2021-09-20
N214916-001	10138270	2027-11-12	U-3204		2021-09-20
N214916-001	10793596	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20
N214916-001	7713937	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20
N214916-001	7727963	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20
N214916-001	8217007	2027-11-12	U-3204		2021-09-20
N214916-001	8236766	2027-11-12	U-3204		2021-09-20
N214916-001	8486894	2027-11-12	U-3204		2021-09-20
N214916-001	8536131	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20
N214916-001	9334305	2027-11-12	U-3204		2021-09-20
N214916-001	9359399	2027-11-12	U-3204		2021-09-20
N214916-001	7402564	2032-11-12	U-3204	Drug substance, Drug product	2021-09-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214916-001	NCE	2026-08-23

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.

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	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214916-001	KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-08-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 396 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214916-001	10017536	2027-11-12	U-3204	Drug substance	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	10138270	2027-11-12	U-3204		2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	10793596	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	7402564	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	7713937	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	7727963	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	8217007	2027-11-12	U-3204		2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	8236766	2027-11-12	U-3204		2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	8486894	2027-11-12	U-3204		2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	8536131	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	9334305	2027-11-12	U-3204		2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214916-001	9359399	2027-11-12	U-3204		2021-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	10017536	2027-11-12	U-3204	Drug substance	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	10138270	2027-11-12	U-3204		2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	10793596	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	7402564	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	7713937	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	7727963	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	8217007	2027-11-12	U-3204		2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	8236766	2027-11-12	U-3204		2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	8486894	2027-11-12	U-3204		2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	8536131	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	9334305	2027-11-12	U-3204		2021-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	9359399	2027-11-12	U-3204		2021-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214916-001	10017536	2027-11-12	U-3204	Drug substance	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	10138270	2027-11-12	U-3204		2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	10793596	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	7402564	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	7713937	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	7727963	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	8217007	2027-11-12	U-3204		2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	8236766	2027-11-12	U-3204		2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	8486894	2027-11-12	U-3204		2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	8536131	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	9334305	2027-11-12	U-3204		2021-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214916-001	9359399	2027-11-12	U-3204		2021-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214916-001	10017536	2027-11-12	U-3204	Drug substance	2021-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214916-001	10138270	2027-11-12	U-3204		2021-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214916-001	10793596	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214916-001	7402564	2027-11-12	U-3204	Drug substance, Drug product	2021-09-20	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214916-001	NCE	2026-08-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214916-001	NCE	2026-08-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214916-001	NCE	2026-08-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214916-001	NCE	2026-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214916-001	NCE	2026-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214916-001	NCE	2026-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214916-001	NCE	2026-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214916-001	NCE	2026-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214916-001	NCE	2026-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214916-001	NCE	2026-08-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214916-001	NCE	2026-08-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214916-001	NCE	2026-08-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214916-001	NCE	2026-08-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214916-001	NCE	2026-08-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214916-001	NCE	2026-08-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214916-001	NCE	2026-08-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214916-001	NCE	2026-08-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214916-001	NCE	2026-08-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214916-001	NCE	2026-08-23	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214916-001	NCE	2026-08-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214916-001	NCE	2026-08-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214916-001	NCE	2026-08-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214916-001	NCE	2026-08-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214916-001	NCE	2026-08-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214916-001	NCE	2026-08-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214916-001	NCE	2026-08-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214916-001	NCE	2026-08-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214916-001	NCE	2026-08-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214916-001	NCE	2026-08-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214916-001	NCE	2026-08-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214916-001	NCE	2026-08-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214916-001	NCE	2026-08-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214916-001	NCE	2026-08-23	`a50c72e98297…`

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
Korsuva	DIFELIKEFALIN	Vifor (International), Inc.	0c7b81f2-0fd3-47cb-8b0f-185e07f19c87	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214916 application number: NDA214916 ndc (product): 59353-065

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59353-065	Korsuva	Difelikefalin	Vifor (International) Inc.	NDA	Current
59353-065	Korsuva	Difelikefalin	Vifor (International) Inc.	NDA	Current
59353-065	Korsuva	Difelikefalin	Vifor (International) Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83909	SUPPL	2025-10-24
68656	ORIG	2021-09-20
68457	ORIG	2021-08-25
68452	ORIG	2021-08-24