Application 211844

Type: NDA
Sponsor: INFORLIFE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDAZOLAM	MIDAZOLAM	UNKNOWN	UNKNOWN	Yes	No
002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	SOLUTION;INTRAVENOUS	100MG/100ML (1MG/ML)	Yes	Yes

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

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
N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22
N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	MIDAZOLAM	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N211844-001	AP
N211844-002	AP

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211844-001	10966990	2038-06-20		Drug product	2021-04-16
N211844-002	10966990	2038-06-20		Drug product	2021-04-16

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.

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
2026-08-01 22:54:32	2026-06	N211844-001	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	50MG/50ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211844-002	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2021-03-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N211844-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211844-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N211844-001	10966990	2038-06-20		Drug product	2021-04-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N211844-002	10966990	2038-06-20		Drug product	2021-04-16	`a50c72e98297…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam in Sodium Chloride	MIDAZOLAM	WG Critical Care, LLC.	f051776f-94c5-4e34-80ed-f45b9c36881e	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211844 application number: NDA211844 ndc (product): 44567-611 ndc (product): 44567-610

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-610	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-610	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-610	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-610	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-610	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-611	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-611	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-611	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-611	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current
44567-611	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	WG Critical Care, LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79143	SUPPL	2024-07-22
73217	SUPPL	2023-01-17
73188	SUPPL	2023-01-17
69040	SUPPL	2021-10-20
68046	ORIG	2021-07-12
66859	ORIG	2021-03-24
66836	ORIG	2021-03-23