Application 075873

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	SYRUP;ORAL	EQ 2MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075873-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075873-001	AA

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 2 · 42 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	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A075873-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075873-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075873-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075873-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075873-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075873-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075873-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075873-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075873-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075873-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075873-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075873-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075873-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075873-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075873-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075873-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075873-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075873-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075873-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075873-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075873-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075873-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075873-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075873-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075873-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075873-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075873-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075873-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075873-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075873-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075873-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075873-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075873-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075873-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075873-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075873-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075873-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075873-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075873-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075873-001	AA	1	`e64feba35796…`

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	American Health Packaging	fc93242b-0abf-466a-8413-8a365620ee75	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075873 application number: ANDA075873 ndc (product): 60687-576
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Precision Dose Inc.	9a443652-6aff-4e27-83fe-90c65fa0f3c1	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075873 application number: ANDA075873 ndc (product): 68094-764
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Precision Dose Inc.	557ef7bf-9341-47f9-804d-430a24982fa6	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075873 application number: ANDA075873 ndc (product): 68094-762
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	a833c24b-6dca-44d7-a0d6-20012fa1ea77	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075873 application number: ANDA075873 ndc (product): 0054-3566

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-3566	Midazolam Hydrochloride	Midazolam Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3566	Midazolam Hydrochloride	Midazolam Hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3566	Midazolam Hydrochloride	Midazolam Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3566	Midazolam Hydrochloride	Midazolam Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0904-7113	Midazolam Hydrochloride	Midazolam Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7114	Midazolam Hydrochloride	Midazolam Hydrochloride	Major Pharmaceuticals	ANDA	Current
17856-3566	Midazolam Hydrochloride	Midazolam Hydrochloride	Atlantic Biologicals Corps	ANDA	Current
17856-3566	Midazolam Hydrochloride	Midazolam Hydrochloride	Atlantic Biologicals Corps	ANDA	Current
17856-3566	Midazolam Hydrochloride	Midazolam Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
60687-576	Midazolam Hydrochloride	Midazolam Hydrochloride	American Health Packaging	ANDA	Current
60687-576	Midazolam Hydrochloride	Midazolam Hydrochloride	American Health Packaging	ANDA	Current
68094-762	Midazolam Hydrochloride	Midazolam Hydrochloride	Precision Dose Inc.	ANDA	Current
68094-762	Midazolam Hydrochloride	Midazolam Hydrochloride	Precision Dose Inc.	ANDA	Current
68094-762	Midazolam Hydrochloride	Midazolam Hydrochloride	Precision Dose Inc.	ANDA	Current
68094-764	Midazolam Hydrochloride	Midazolam Hydrochloride	Precision Dose Inc.	ANDA	Current
68094-764	Midazolam Hydrochloride	Midazolam Hydrochloride	Precision Dose Inc.	ANDA	Current
68094-764	Midazolam Hydrochloride	Midazolam Hydrochloride	Precision Dose Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8817	ORIG	2003-04-10