Application 090316

Type: ANDA
Sponsor: MYLAN ASI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No
002	MIDOZALAM HYDROCHLORIDE	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
A090316-001	MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP		2011-05-04
A090316-002	MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2011-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090316-001	AP
A090316-002	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	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2011-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090316-001	MIDOZALAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090316-002	MIDOZALAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2011-05-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090316-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090316-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090316-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090316-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090316-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090316-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090316-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090316-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090316-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090316-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090316-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090316-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090316-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090316-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090316-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090316-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090316-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090316-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090316-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090316-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090316-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090316-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090316-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090316-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090316-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090316-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090316-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090316-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090316-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090316-002	AP	1	`8072bd15b7f6…`
2019-09-15 20:21 UTC	2019-09	A090316-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090316-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090316-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090316-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090316-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090316-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090316-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090316-002	AP	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090316-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090316-002	AP	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam	MIDAZOLAM HYDROCHLORIDE	Onesource Specialty Pharma Limited	a0e9a149-7a4c-4f66-91af-91695ee2e40c	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090316 application number: ANDA090316
Midazolam	MIDAZOLAM HYDROCHLORIDE	Steriscience Specialties Private Limited	473fba4b-8754-4b1d-bba9-d9c8f6d818e0	2023-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090316 application number: ANDA090316
Midazolam	MIDAZOLAM HYDROCHLORIDE	SOMERSET THERAPEUTICS, LLC	06e4f754-72df-4eb4-aaed-b538524f5277	2023-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090316 application number: ANDA090316