Application 075494

Type: ANDA
Sponsor: AKORN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No
002	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075494-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2000-06-30
A075494-002	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2000-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075494-001	AP
A075494-002	AP

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075494-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075494-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075494-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075494-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075494-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075494-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075494-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075494-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075494-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075494-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075494-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075494-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075494-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075494-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075494-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075494-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075494-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075494-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075494-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075494-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075494-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075494-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075494-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075494-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075494-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075494-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075494-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075494-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075494-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075494-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075494-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075494-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075494-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075494-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075494-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075494-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075494-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075494-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075494-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075494-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075494-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075494-002	AP	1	`74a2ff9319b5…`

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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam	MIDAZOLAM HYDROCHLORIDE	Steriscience Specialties Private Limited	473fba4b-8754-4b1d-bba9-d9c8f6d818e0	2023-12-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	SOMERSET THERAPEUTICS, LLC	74666098-1ca8-4c06-8fc4-5de870b1b514	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	SOMERSET THERAPEUTICS, LLC	06e4f754-72df-4eb4-aaed-b538524f5277	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
midazolam	MIDAZOLAM HYDROCHLORIDE	Sagent Pharmaceuticals	880cac48-5c0f-49a9-8aef-3c9770bf5d84	2023-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
midazolam	MIDAZOLAM HYDROCHLORIDE	Sagent Pharmaceuticals	e22611dd-1830-40af-9139-7cdb07f5a426	2023-11-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Bryant Ranch Prepack	1a701d59-3a30-4a4b-a5dd-51f01ba9c5cc	2023-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Gland Pharma Limited	81b2f48d-a05c-4301-8fee-761af220d44f	2023-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam hydrochloride	MIDAZOLAM HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	843cc25e-45ea-4372-ae34-843f805fa869	2023-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Padagis US LLC	0be63f63-6a93-4782-8f9c-d13ca5ae44bd	2022-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam hydrochloride	MIDAZOLAM HYDROCHLORIDE	Gland Pharma Limited	23f4df96-1151-4815-8f01-4d79e5aa2145	2022-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE

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
17478-523	Midazolam	Midazolam Hydrochloride	Akorn, Inc.	ANDA	Current
17478-523	Midazolam	Midazolam Hydrochloride	Akorn	ANDA	Current
17478-523	Midazolam	Midazolam Hydrochloride	Akorn	ANDA	Current
17478-523	Midazolam	Midazolam Hydrochloride	Akorn, Inc.	ANDA	Current
17478-523	Midazolam	Midazolam Hydrochloride	Akorn, Inc.	ANDA	Current
17478-524	Midazolam	Midazolam Hydrochloride	Akorn, Inc.	ANDA	Current
17478-524	Midazolam	Midazolam Hydrochloride	Akorn	ANDA	Current
17478-524	Midazolam	Midazolam Hydrochloride	Akorn	ANDA	Current
17478-524	Midazolam	Midazolam Hydrochloride	Akorn, Inc.	ANDA	Current
17478-524	Midazolam	Midazolam Hydrochloride	Akorn, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8692	ORIG	2000-06-30