Application 075243

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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 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
A075243-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2000-06-20
A075243-002	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		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
A075243-001	AP
A075243-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075243-001	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2000-06-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075243-002	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	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	A075243-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075243-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075243-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075243-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075243-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075243-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075243-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075243-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075243-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075243-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075243-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075243-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075243-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075243-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075243-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075243-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075243-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075243-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075243-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075243-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075243-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075243-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075243-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075243-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075243-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075243-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075243-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075243-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075243-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075243-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075243-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075243-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075243-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075243-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075243-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075243-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075243-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075243-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075243-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075243-002	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam	MIDAZOLAM	Henry Schein, Inc.	3c2fd6ee-4ede-4ee4-8c05-34c93598f381	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243 ndc (product): 0404-9913
Midazolam	MIDAZOLAM	Henry Schein, Inc.	78e28b13-414e-4c34-a42c-caf1c3ba1f54	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243
Midazolam	MIDAZOLAM	Henry Schein, Inc.	94e1342b-f597-44c0-b8fc-b753fde04cbe	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243
Midazolam	MIDAZOLAM	Civica, Inc.	f0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243 ndc (product): 72572-430 ndc (product): 72572-432
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	f8bb3427-c887-47b6-8042-8a21dc161c79	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243 ndc (product): 0641-6190
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	8675cdb1-c7f5-40cf-b1e0-0960b7ab117b	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243 ndc (product): 0641-6210 ndc (product): 0641-6211 ndc (product): 0641-6209
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	575d8bf0-7af7-427c-a231-966e2a5e070d	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075243 application number: ANDA075243 ndc (product): 0641-6059 ndc (product): 0641-6061 ndc (product): 0641-6057 ndc (product): 0641-6060 ndc (product): 0641-6056 ndc (product): 0641-6063

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9913	Midazolam	Midazolam	Henry Schein, Inc.	ANDA	Current
0404-9913	Midazolam	Midazolam	Henry Schein, Inc.	ANDA	Current
0641-6056	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6056	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6057	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6057	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6059	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6059	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6060	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6060	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6061	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6061	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6063	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6063	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6190	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6190	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6209	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6209	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6210	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6210	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6211	Midazolam	Midazolam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6211	Midazolam	Midazolam	West-Ward Pharmaceuticals Corp.	ANDA	Current
50090-0683	Midazolam	Midazolam	A-S Medication Solutions	ANDA	Current
50090-0738	Midazolam	Midazolam	A-S Medication Solutions	ANDA	Current
52584-055	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-055	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-056	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-056	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-059	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-059	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-059	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
52584-059	Midazolam	Midazolam	General Injectables and Vaccines, Inc.	ANDA	Current
55154-2889	Midazolam	Midazolam	Cardinal Health	ANDA	Current
55154-2889	Midazolam	Midazolam	Cardinal Health	ANDA	Current
72572-430	Midazolam	Midazolam	Civica, Inc.	ANDA	Current
72572-430	Midazolam	Midazolam	Civica, Inc.	ANDA	Current
72572-432	Midazolam	Midazolam	Civica, Inc.	ANDA	Current
72572-432	Midazolam	Midazolam	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30813	ORIG	2004-06-09
8579	ORIG	2000-06-20