Application 209360

Type: NDA
Sponsor: LA JOLLA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GIAPREZA	ANGIOTENSIN II ACETATE	SOLUTION;INTRAVENOUS	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	Yes	Yes
002	GIAPREZA	ANGIOTENSIN II ACETATE	SOLUTION;INTRAVENOUS	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	Yes	No
003	GIAPREZA	ANGIOTENSIN II ACETATE	SOLUTION;INTRAVENOUS	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	RLD / RS	Approval date
N209360-001	GIAPREZA	ANGIOTENSIN II ACETATE	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-12-21
N209360-002	GIAPREZA	ANGIOTENSIN II ACETATE	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21
N209360-003	GIAPREZA	ANGIOTENSIN II ACETATE	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209360-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 45 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N209360-001	10335451	2029-12-16	U-2581	2019-07-26
N209360-001	10500247	2029-12-16	U-2680	2019-12-20
N209360-001	10500247	2029-12-16	U-2681	2019-12-20
N209360-001	10548943	2029-12-16	U-2739	2020-02-20
N209360-001	10548943	2029-12-16	U-2740	2020-02-20
N209360-001	9867863	2029-12-16	U-2231	2018-02-14
N209360-001	9572856	2031-07-18	U-2221	2018-01-22
N209360-001	10028995	2034-12-18	U-2338	2018-08-02
N209360-001	10493124	2034-12-18	U-2679	2019-12-20
N209360-001	11096983	2034-12-18	U-3211	2021-09-23
N209360-001	11096983	2034-12-18	U-3212	2021-09-23
N209360-001	11559559	2034-12-18	U-3514	2023-02-08
N209360-001	9220745	2034-12-18	U-2217	2018-01-22
N209360-001	9220745	2034-12-18	U-2218	2018-01-22
N209360-001	11219662	2037-01-06	U-3262	2022-01-11
N209360-002	10335451	2029-12-16	U-2581	2019-07-26
N209360-002	10500247	2029-12-16	U-2680	2019-12-20
N209360-002	10500247	2029-12-16	U-2681	2019-12-20
N209360-002	10548943	2029-12-16	U-2739	2020-02-20
N209360-002	10548943	2029-12-16	U-2740	2020-02-20
N209360-002	9867863	2029-12-16	U-2231	2018-02-14
N209360-002	9572856	2030-11-20	U-2221	2018-01-22
N209360-002	10028995	2034-12-18	U-2338	2018-08-02
N209360-002	10493124	2034-12-18	U-2679	2019-12-20
N209360-002	11096983	2034-12-18	U-3211	2021-09-23
N209360-002	11096983	2034-12-18	U-3212	2021-09-23
N209360-002	11559559	2034-12-18	U-3514	2023-02-08
N209360-002	9220745	2034-12-18	U-2217	2018-01-22
N209360-002	9220745	2034-12-18	U-2218	2018-01-22
N209360-002	11219662	2037-01-06	U-3262	2022-01-11
N209360-003	10335451	2029-12-16	U-2581	2022-01-21
N209360-003	10500247	2029-12-16	U-2680	2022-01-21
N209360-003	10500247	2029-12-16	U-2681	2022-01-21
N209360-003	10548943	2029-12-16	U-2739	2022-01-21
N209360-003	10548943	2029-12-16	U-2740	2022-01-21
N209360-003	9867863	2029-12-16	U-2231	2022-01-21
N209360-003	9572856	2031-07-18	U-2221	2022-01-21
N209360-003	10028995	2034-12-18	U-2338	2022-01-21
N209360-003	10493124	2034-12-18	U-2679	2022-01-21
N209360-003	11096983	2034-12-18	U-3211	2022-01-21
N209360-003	11096983	2034-12-18	U-3212	2022-01-21
N209360-003	11559559	2034-12-18	U-3514	2023-02-08
N209360-003	9220745	2034-12-18	U-2217	2022-01-21
N209360-003	9220745	2034-12-18	U-2218	2022-01-21
N209360-003	11219662	2037-01-06	U-3262	2022-01-11

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 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2017-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209360-002	GIAPREZA	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2017-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209360-003	GIAPREZA	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209360-001	GIAPREZA	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2017-12-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N209360-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209360-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209360-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209360-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209360-001	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209360-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 42 · 1,663 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209360-001	10335451	2029-12-16	U-2581	2019-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10500247	2029-12-16	U-2681	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10500247	2029-12-16	U-2680	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10548943	2029-12-16	U-2740	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10548943	2029-12-16	U-2739	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	9867863	2029-12-16	U-2231	2018-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	9572856	2031-07-18	U-2221	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10028995	2034-12-18	U-2338	2018-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	10493124	2034-12-18	U-2679	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	11096983	2034-12-18	U-3211	2021-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	11096983	2034-12-18	U-3212	2021-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	11559559	2034-12-18	U-3514	2023-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	9220745	2034-12-18	U-2218	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	9220745	2034-12-18	U-2217	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-001	11219662	2037-01-06	U-3262	2022-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10335451	2029-12-16	U-2581	2019-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10500247	2029-12-16	U-2681	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10500247	2029-12-16	U-2680	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10548943	2029-12-16	U-2740	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10548943	2029-12-16	U-2739	2020-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	9867863	2029-12-16	U-2231	2018-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	9572856	2030-11-20	U-2221	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10028995	2034-12-18	U-2338	2018-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	10493124	2034-12-18	U-2679	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	11096983	2034-12-18	U-3211	2021-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	11096983	2034-12-18	U-3212	2021-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	11559559	2034-12-18	U-3514	2023-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	9220745	2034-12-18	U-2217	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	9220745	2034-12-18	U-2218	2018-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-002	11219662	2037-01-06	U-3262	2022-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10335451	2029-12-16	U-2581	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10500247	2029-12-16	U-2681	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10500247	2029-12-16	U-2680	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10548943	2029-12-16	U-2740	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10548943	2029-12-16	U-2739	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	9867863	2029-12-16	U-2231	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	9572856	2031-07-18	U-2221	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10028995	2034-12-18	U-2338	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	10493124	2034-12-18	U-2679	2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209360-003	11096983	2034-12-18	U-3212	2022-01-21	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 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	N209360-001	NCE	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209360-002	NCE	2022-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209360-003	NCE	2022-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209360-001	NCE	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209360-002	NCE	2022-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209360-003	NCE	2022-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209360-001	NCE	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209360-002	NCE	2022-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209360-003	NCE	2022-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209360-001	NCE	2022-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209360-002	NCE	2022-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209360-001	NCE	2022-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209360-002	NCE	2022-12-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209360-003	NCE	2022-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209360-001	NCE	2022-12-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209360-002	NCE	2022-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209360-001	NCE	2022-12-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209360-002	NCE	2022-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209360-001	NCE	2022-12-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209360-002	NCE	2022-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209360-001	NCE	2022-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209360-002	NCE	2022-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209360-001	NCE	2022-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209360-002	NCE	2022-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209360-001	NCE	2022-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209360-002	NCE	2022-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209360-001	NCE	2022-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209360-002	NCE	2022-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209360-001	NCE	2022-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209360-002	NCE	2022-12-21	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N209360-001	NCE	2022-12-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N209360-002	NCE	2022-12-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N209360-003	NCE	2022-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209360-001	NCE	2022-12-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209360-002	NCE	2022-12-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209360-003	NCE	2022-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209360-001	NCE	2022-12-21	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N209360-002	NCE	2022-12-21	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N209360-003	NCE	2022-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209360-001	NCE	2022-12-21	`e64feba35796…`

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
Giapreza	ANGIOTENSIN II	La Jolla Pharmaceutical Company	c265d69a-3efe-4107-9a9e-e6fd3d531c48	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209360 application number: NDA209360 ndc (product): 68547-501 ndc (product): 68547-005

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68547-005	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-005	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-501	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-501	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-501	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-501	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-501	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-501	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-501	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current
68547-501	Giapreza	angiotensin II	La Jolla Pharmaceutical Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52233	ORIG	2018-01-31
50923	ORIG	2017-12-27
50866	ORIG	2017-12-26