Application 215868

Type: NDA
Sponsor: EXELA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	SOLUTION;INTRAVENOUS	50MG/50ML (1MG/ML)	No	No
002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	SOLUTION;INTRAVENOUS	100MG/100ML (1MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2022-07-20
N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD	2022-07-20

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 2 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-20	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215868-001	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215868-002	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-20	`a50c72e98297…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam	MIDAZOLAM	Civica, Inc.	f0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Midazolam	MIDAZOLAM	Henry Schein, Inc.	3c2fd6ee-4ede-4ee4-8c05-34c93598f381	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Midazolam	MIDAZOLAM	Henry Schein, Inc.	78e28b13-414e-4c34-a42c-caf1c3ba1f54	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Midazolam	MIDAZOLAM	Henry Schein, Inc.	90f7b7f6-d0fd-40af-bbfa-70b152e3e27c	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
MIDAZOLAM IN 0.8% SODIUM CHLORIDE	MIDAZOLAM IN 0.8% SODIUM CHLORIDE	B. Braun Medical Inc.	adfe8ece-496d-4118-9990-a1d44d0ac7d9	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MIDAZOLAM IN 0.8% SODIUM CHLORIDE
Midazolam	MIDAZOLAM	Henry Schein, Inc.	94e1342b-f597-44c0-b8fc-b753fde04cbe	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	f8bb3427-c887-47b6-8042-8a21dc161c79	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	8675cdb1-c7f5-40cf-b1e0-0960b7ab117b	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	575d8bf0-7af7-427c-a231-966e2a5e070d	2024-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Midazolam	MIDAZOLAM	Hikma Pharmaceuticals USA Inc.	51c8bfa4-5c78-4b7a-9ffb-8f00828acadc	2024-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Midazolam	MIDAZOLAM	Micro Labs Limited	9221894f-d840-46f2-a11c-6b71358d3b5b	2023-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM
Nayzilam	MIDAZOLAM	UCB, Inc.	2b29422e-54d5-4a49-8522-e9cf752368c3	2023-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MIDAZOLAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-2130	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	Exela Pharma Sciences, LLC	NDA	Current
51754-2130	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	Exela Pharma Sciences, LLC	NDA	Current
51754-2131	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	Exela Pharma Sciences, LLC	NDA	Current
51754-2131	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	Exela Pharma Sciences, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74647	ORIG	2023-06-29
73218	SUPPL	2023-01-17
73192	SUPPL	2023-01-17
71619	ORIG	2022-07-22
71618	ORIG	2022-07-21