Application 020942

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERSED	MIDAZOLAM HYDROCHLORIDE	SYRUP;ORAL	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N020942-001	VERSED	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	1998-10-15

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020942-001	VERSED	EQ 2MG BASE/ML	SYRUP / ORAL	RLD	1998-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020942-001	VERSED	EQ 2MG BASE/ML	SYRUP / ORAL	RLD	1998-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	1998-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020942-001	VERSED	EQ 2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	1998-10-15	`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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIDAZOLAM	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	b95415fa-17c2-42ab-a6b0-e628d01c94ed	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	Onesource Specialty Pharma Limited	a0e9a149-7a4c-4f66-91af-91695ee2e40c	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam	MIDAZOLAM HYDROCHLORIDE	Hospira, Inc.	1abda8b8-48a8-4995-af86-39220d1aa240	2026-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	A-S Medication Solutions	5e85e477-d483-4345-8d7b-d7dcdc3e0652	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM HYDROCHLORIDE
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	American Health Packaging	fc93242b-0abf-466a-8413-8a365620ee75	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 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 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 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 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 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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
26259	ORIG	2004-06-30
41826	ORIG	2003-08-08