Application 019008

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	INJECTABLE;INJECTION	800MG/100ML	No	No
002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	INJECTABLE;INJECTION	200MG/100ML	No	No
003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	INJECTABLE;INJECTION	400MG/100ML	No	No

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	Approval date
N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	800MG/100ML	INJECTABLE / INJECTION	1986-04-29
N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	200MG/100ML	INJECTABLE / INJECTION	1986-04-29
N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	BRETYLIUM TOSYLATE	400MG/100ML	INJECTABLE / INJECTION	1986-04-29

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019008-002	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION	1986-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019008-003	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION	1986-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019008-001	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	INJECTABLE / INJECTION	1986-04-29	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Application 019008

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Reported adverse events (FAERS/openFDA)#