Application 203460

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No
002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2014-08-22
A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2014-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203460-001	AP
A203460-002	AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203460-001	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203460-002	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2014-08-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203460-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203460-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203460-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203460-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203460-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203460-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203460-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203460-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203460-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203460-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203460-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203460-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203460-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203460-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203460-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203460-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203460-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203460-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203460-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203460-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203460-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203460-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203460-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203460-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203460-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203460-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203460-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203460-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203460-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203460-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203460-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203460-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203460-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203460-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203460-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203460-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203460-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203460-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203460-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203460-002	AP	1	`bb7c543d1eb4…`

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
Midazolam	MIDAZOLAM HYDROCHLORIDE	Fresenius Kabi USA, LLC	1cc9ba6e-fa1b-405e-9de8-720c567b2a73	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203460 application number: ANDA203460 ndc (product): 76045-002 ndc (product): 76045-003 ndc (product): 76045-001 ndc (product): 76045-211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76045-001	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-001	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-001	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-001	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-002	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-002	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-002	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-002	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-003	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-003	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-003	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-003	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
76045-211	Midazolam	Midazolam Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current