Application 076755

Type: ANDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUMAZENIL	FLUMAZENIL	INJECTABLE;INJECTION	1MG/10ML (0.1MG/ML)	No	No
002	FLUMAZENIL	FLUMAZENIL	INJECTABLE;INJECTION	0.5MG/5ML (0.1MG/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
A076755-001	FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2004-10-12
A076755-002	FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2004-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076755-001	AP
A076755-002	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	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION		2004-10-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION		2004-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076755-001	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076755-002	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	2004-10-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A076755-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076755-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076755-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076755-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076755-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076755-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076755-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076755-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076755-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076755-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076755-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076755-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076755-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076755-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076755-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076755-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076755-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076755-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076755-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076755-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076755-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076755-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076755-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076755-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076755-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076755-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076755-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076755-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076755-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076755-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076755-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076755-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076755-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076755-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076755-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076755-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A076755-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076755-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076755-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076755-002	AP	1	`782e0a99824c…`

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
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	28f31b54-ff30-fd0d-e063-6394a90afc18	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076755 application number: ANDA076755
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	9f68c61a-c207-cdbe-e053-2a95a90af5a0	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076755 application number: ANDA076755 ndc (product): 71872-7206
Flumazenil	FLUMAZENIL	Baxter Healthcare Corporation	8175c1eb-80af-48f1-813c-c8f0e736d894	2020-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076755 application number: ANDA076755 ndc (product): 36000-149 ndc (product): 36000-148

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9859	Flumazenil	flumazenil	Henry Schein, Inc	ANDA	Current
0404-9859	Flumazenil	flumazenil	Henry Schein, Inc	ANDA	Current
0404-9860	Flumazenil	flumazenil	Henry Schein, Inc	ANDA	Current
0404-9860	Flumazenil	flumazenil	Henry Schein, Inc	ANDA	Current
36000-148	Flumazenil	Flumazenil	Baxter Healthcare Corporation	ANDA	Current
36000-148	Flumazenil	Flumazenil	Baxter Healthcare Corporation	ANDA	Current
36000-148	Flumazenil	Flumazenil	Baxter Healthcare Corporation	ANDA	Current
36000-148	Flumazenil	Flumazenil	Baxter Healthcare Corporation	ANDA	Current
36000-149	Flumazenil	Flumazenil	Baxter Healthcare Corporation	ANDA	Current
36000-149	Flumazenil	Flumazenil	Baxter Healthcare Corporation	ANDA	Current
36000-149	Flumazenil	Flumazenil	Baxter Healthcare Corporation	ANDA	Current
36000-149	Flumazenil	Flumazenil	Baxter Healthcare Corporation	ANDA	Current
52584-088	Flumazenil	flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
52584-088	Flumazenil	flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
52584-088	Flumazenil	flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
52584-089	Flumazenil	flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
52584-089	Flumazenil	flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
52584-089	Flumazenil	flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
52584-089	Flumazenil	flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
71872-7206	Flumazenil	Flumazenil	Medical Purchasing Solutions, LLC	ANDA	Current