Application 000734

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HISTAMINE PHOSPHATE	HISTAMINE PHOSPHATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No
002	HISTAMINE PHOSPHATE	HISTAMINE PHOSPHATE	INJECTABLE;INJECTION	EQ 0.2MG BASE/ML	No	No
003	HISTAMINE PHOSPHATE	HISTAMINE PHOSPHATE	INJECTABLE;INJECTION	EQ 0.1MG BASE/ML	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	RLD / RS
N000734-001	HISTAMINE PHOSPHATE	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982
N000734-002	HISTAMINE PHOSPHATE	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982
N000734-003	HISTAMINE PHOSPHATE	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N000734-002	HISTAMINE PHOSPHATE	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N000734-003	HISTAMINE PHOSPHATE	EQ 0.1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N000734-001	HISTAMINE PHOSPHATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`

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
Histamine Positive Skin Test Control	HISTAMINE PHOSPHATE	ALK-Abello, Inc.	1159c24c-d9ce-49a2-b0bd-dc27c710f146	2020-08-28	Warnings, Adverse reactions	Name fallback generic name: HISTAMINE PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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