Application 075484

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 5MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075484-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION			2000-06-20

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075484-001	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2000-06-20	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 28 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	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	Onesource Specialty Pharma Limited	54ed43b2-bad1-4b45-e063-6294a90a793a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam hydrochloride	MIDAZOLAM HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8b690f5c-2923-4c34-a8f7-11af5f546b62	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	Cardinal Health 107, LLC	cbedf0bf-82a4-4214-96d5-01ac35e101f0	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Precision Dose Inc.	9a443652-6aff-4e27-83fe-90c65fa0f3c1	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	b95415fa-17c2-42ab-a6b0-e628d01c94ed	2026-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	1abda8b8-48a8-4995-af86-39220d1aa240	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	affecd4d-1f78-4bbe-5a8d-86849bbdc520	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	b7effb82-e180-46f0-b2e8-a0d8ebc32a2a	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Jvet Pharmaceuticals LLC	a84ddd02-1f5f-4311-9dae-2a5cb4064bf3	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	REMEDYREPACK INC.	d9305142-417d-4d8c-9a23-f9a1b6771cac	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Precision Dose Inc.	557ef7bf-9341-47f9-804d-430a24982fa6	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Henry Schein, Inc.	9e3bd5d3-36b3-471c-b8cc-ef48645700c2	2025-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	a833c24b-6dca-44d7-a0d6-20012fa1ea77	2025-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam in Sodium Chloride	MIDAZOLAM HYDROCHLORIDE	Sagent Pharmaceuticals	c546cfd4-4f2b-4b94-aa47-995595f1a146	2025-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Belcher Pharmaceuticals, LLC	cee4cdd0-58c5-4704-9fb6-d4bffb1764a8	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Midazolam Hydrochloride generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	Fresenius Kabi USA, LLC	a91ce254-14a3-4cbf-8ab8-5da252aa3fdc	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	Fresenius Kabi USA, LLC	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	2024-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30910	ORIG	2000-06-20