Application 207078

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	FOR SUSPENSION;ORAL	5GM/PACKET	Yes	No
002	LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	FOR SUSPENSION;ORAL	10GM/PACKET	Yes	Yes

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

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
N207078-001	LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	5GM/PACKET	FOR SUSPENSION / ORAL		RLD	2018-05-18
N207078-002	LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	10GM/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2018-05-18

Orange Book patents#

Current patent rows page 1 of 1 · 27 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207078-001	10335432	2032-02-10	U-2312		2019-07-25
N207078-001	10398730	2032-02-10	U-2312		2019-10-01
N207078-001	10413569	2032-02-10		Drug substance	2019-10-01
N207078-001	11406662	2032-02-10		Drug substance	2022-09-07
N207078-001	8808750	2032-02-10	U-2312		2018-06-12
N207078-001	9844567	2032-02-10	U-2312		2018-06-12
N207078-001	9861658	2032-02-10	U-2312		2018-06-12
N207078-001	8802152	2032-04-19		Drug substance	2018-06-12
N207078-001	10695365	2033-10-22		Drug substance	2020-07-28
N207078-001	8877255	2033-10-22		Drug substance	2018-06-12
N207078-001	9913860	2033-10-22	U-2312	Drug substance	2019-01-23
N207078-001	10300087	2035-10-14	U-2312	Drug substance	2019-07-25
N207078-001	11738044	2035-10-14	U-2312		2023-09-21
N207078-001	9592253	2035-10-14	U-2312	Drug substance	2018-06-12
N207078-002	10398730	2032-02-10	U-2312		2019-10-01
N207078-002	10413569	2032-02-10		Drug substance	2019-10-01
N207078-002	11406662	2032-02-10		Drug substance	2022-09-07
N207078-002	8808750	2032-02-10	U-2312		2018-06-12
N207078-002	9844567	2032-02-10	U-2312		2018-06-12
N207078-002	9861658	2032-02-10	U-2312		2018-06-12
N207078-002	8802152	2032-04-19		Drug substance	2018-06-12
N207078-002	10695365	2033-10-22		Drug substance	2020-07-28
N207078-002	8877255	2033-10-22		Drug substance	2018-06-12
N207078-002	9913860	2033-10-22	U-2312	Drug substance	2019-01-23
N207078-002	10300087	2035-10-14	U-2312	Drug substance	2019-07-25
N207078-002	11738044	2035-10-14	U-2312		2023-09-21
N207078-002	9592253	2035-10-14	U-2312	Drug substance	2018-06-12

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 3 · 82 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	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207078-001	LOKELMA	5GM/PACKET	FOR SUSPENSION / ORAL	RLD	2018-05-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207078-002	LOKELMA	10GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2018-05-18	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,026 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	N207078-001	10335432	2032-02-10	U-2312		2019-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	10398730	2032-02-10	U-2312		2019-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	10413569	2032-02-10		Drug substance	2019-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	11406662	2032-02-10		Drug substance	2022-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	8808750	2032-02-10	U-2312		2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	9844567	2032-02-10	U-2312		2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	9861658	2032-02-10	U-2312		2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	8802152	2032-04-19		Drug substance	2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	10695365	2033-10-22		Drug substance	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	8877255	2033-10-22		Drug substance	2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	9913860	2033-10-22	U-2312	Drug substance	2019-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	10300087	2035-10-14	U-2312	Drug substance	2019-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	11738044	2035-10-14	U-2312		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-001	9592253	2035-10-14	U-2312	Drug substance	2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	10398730	2032-02-10	U-2312		2019-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	10413569	2032-02-10		Drug substance	2019-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	11406662	2032-02-10		Drug substance	2022-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	8808750	2032-02-10	U-2312		2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	9844567	2032-02-10	U-2312		2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	9861658	2032-02-10	U-2312		2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	8802152	2032-04-19		Drug substance	2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	10695365	2033-10-22		Drug substance	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	8877255	2033-10-22		Drug substance	2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	9913860	2033-10-22	U-2312	Drug substance	2019-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	10300087	2035-10-14	U-2312	Drug substance	2019-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	11738044	2035-10-14	U-2312		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207078-002	9592253	2035-10-14	U-2312	Drug substance	2018-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	10335432	2032-02-10	U-2312		2019-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	10398730	2032-02-10	U-2312		2019-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	10413569	2032-02-10		Drug substance	2019-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	11406662	2032-02-10		Drug substance	2022-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	8808750	2032-02-10	U-2312		2018-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	9844567	2032-02-10	U-2312		2018-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	9861658	2032-02-10	U-2312		2018-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	8802152	2032-04-19		Drug substance	2018-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	10695365	2033-10-22		Drug substance	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	8877255	2033-10-22		Drug substance	2018-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	9913860	2033-10-22	U-2312	Drug substance	2019-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	10300087	2035-10-14	U-2312	Drug substance	2019-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207078-001	11738044	2035-10-14	U-2312		2023-09-21	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-001	M-261	2023-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-001	NCE	2023-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-002	M-261	2023-04-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207078-002	NCE	2023-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207078-001	M-261	2023-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207078-001	NCE	2023-05-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207078-002	M-261	2023-04-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207078-002	NCE	2023-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207078-001	M-261	2023-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207078-001	NCE	2023-05-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207078-002	M-261	2023-04-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207078-002	NCE	2023-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207078-001	NCE	2023-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207078-002	NCE	2023-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207078-001	M-261	2023-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207078-001	NCE	2023-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207078-002	M-261	2023-04-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207078-002	NCE	2023-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207078-001	M-261	2023-04-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207078-001	NCE	2023-05-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207078-002	M-261	2023-04-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207078-002	NCE	2023-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207078-001	M-261	2023-04-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207078-001	NCE	2023-05-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207078-002	M-261	2023-04-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207078-002	NCE	2023-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207078-001	M-261	2023-04-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207078-001	NCE	2023-05-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207078-002	M-261	2023-04-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N207078-002	NCE	2023-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207078-001	M-261	2023-04-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207078-001	NCE	2023-05-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207078-002	M-261	2023-04-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207078-002	NCE	2023-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207078-001	M-261	2023-04-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207078-001	NCE	2023-05-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207078-002	M-261	2023-04-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207078-002	NCE	2023-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207078-001	NCE	2023-05-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207078-002	NCE	2023-05-18	`3f01610625f2…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	A-S Medication Solutions	8833d6e6-33ab-4ea9-b78f-3ec30a904ef8	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207078 application number: NDA207078
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	AstraZeneca Pharmaceuticals LP	90bf8e28-748d-4e4b-a19f-9cf483370eff	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207078 application number: NDA207078 ndc (product): 0310-1110 ndc (product): 0310-1105
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	A-S Medication Solutions	7f7ed64d-8480-4143-a207-29c24a0b9363	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207078 application number: NDA207078

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-1105	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1105	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1105	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1105	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1105	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1105	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1105	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1105	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1110	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1110	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1110	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1110	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1110	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1110	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1110	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1110	LOKELMA	sodium zirconium cyclosilicate	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77461	SUPPL	2024-02-12
77443	SUPPL	2024-02-09
72228	SUPPL	2022-10-03
72208	SUPPL	2022-10-03
69042	SUPPL	2021-10-21
69032	SUPPL	2021-10-20
62699	SUPPL	2020-04-28
62681	SUPPL	2020-04-27
54477	ORIG	2018-06-08
54271	ORIG	2018-05-21
54257	ORIG	2018-05-18