Application 075293

Type: ANDA
Sponsor: HOSPIRA

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	Yes
002	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5MG BASE/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075293-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20
A075293-002	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075293-001	AP
A075293-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075293-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075293-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2000-06-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075293-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075293-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075293-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075293-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075293-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075293-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075293-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075293-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075293-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075293-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075293-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075293-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075293-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075293-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075293-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075293-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075293-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075293-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075293-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075293-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075293-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075293-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075293-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075293-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075293-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075293-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075293-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075293-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075293-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075293-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075293-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075293-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075293-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075293-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075293-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075293-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075293-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075293-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075293-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075293-002	AP	1	`bb7c543d1eb4…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	5e85e477-d483-4345-8d7b-d7dcdc3e0652	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075293 application number: ANDA075293 ndc (product): 50090-5342
Midazolam	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	affecd4d-1f78-4bbe-5a8d-86849bbdc520	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075293 application number: ANDA075293 ndc (product): 0409-2587 ndc (product): 0409-2596
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	b7effb82-e180-46f0-b2e8-a0d8ebc32a2a	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075293 application number: ANDA075293 ndc (product): 50090-5472
Midazolam	MIDAZOLAM	Henry Schein, Inc.	90f7b7f6-d0fd-40af-bbfa-70b152e3e27c	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075293 application number: ANDA075293 ndc (product): 0404-9915

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9915	Midazolam	Midazolam	Henry Schein, Inc.	ANDA	Current
0409-2587	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2587	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2587	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2587	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2587	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2587	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2587	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2587	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-2596	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
50090-5342	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-5342	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-5472	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
52584-596	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-596	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-596	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
68258-8981	Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Dispensing Solutions, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52645	SUPPL	2018-02-14
8603	ORIG	2004-06-09
30836	ORIG	2000-06-20