Application 216359

Type: NDA
Sponsor: RAFA LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDAZOLAM	MIDAZOLAM	INJECTABLE;AUTOINJECTOR	10MG/0.7ML	No	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
N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	MIDAZOLAM HYDROCHLORIDE	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR		RLD, RS	2022-08-08

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD	2022-08-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216359-001	MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)	EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)	SOLUTION / INTRAMUSCULAR	RLD, RS	2022-08-08	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
N/A	MIDAZOLAM INJECTION, 10 MG	Rafa Laboratories, Ltd.	d7362b4d-68a3-99a0-e053-2995a90a4f60	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216359 application number: NDA216359 ndc (product): 71053-595

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71053-595	N/A	Midazolam Injection, 10 mg	Rafa Laboratories, Ltd.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78829	SUPPL	2024-06-18
78828	SUPPL	2024-06-18
75391	ORIG	2023-09-12
71762	ORIG	2022-08-09
71750	ORIG	2022-08-08