Application 078527

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

Application Products#

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

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
A078527-001	FLUMAZENIL	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23
A078527-002	FLUMAZENIL	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078527-001	AP
A078527-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078527-001	FLUMAZENIL	0.5MG/5ML (0.1MG/ML)	INJECTABLE / INJECTION	AP		2009-03-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078527-002	FLUMAZENIL	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RS	2009-03-23	`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	A078527-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078527-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078527-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078527-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078527-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078527-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078527-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078527-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078527-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078527-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078527-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078527-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078527-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078527-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078527-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078527-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078527-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078527-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078527-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078527-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078527-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078527-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078527-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078527-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078527-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078527-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078527-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078527-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078527-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078527-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078527-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078527-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078527-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078527-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078527-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078527-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078527-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078527-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078527-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078527-002	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA HealthFirst	74d007e9-9604-0941-e053-2a91aa0a29c4	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527 ndc (product): 51662-1254
Flumazenil	FLUMAZENIL	ProPharma Distribution	3eefb01b-3d6a-a3eb-e063-6394a90a4829	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	ProPharma Distribution	3f7a30b5-2728-0c82-e063-6394a90a92dd	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
FLUMAZENIL	FLUMAZENIL	Henry Schein, Inc.	1855bb03-392f-4a0d-8361-24fc2a0e635e	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
FLUMAZENIL	FLUMAZENIL	Henry Schein, Inc.	3ea41cbe-bc07-4c95-8bb2-7dfc2e96a874	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527
Flumazenil	FLUMAZENIL	Hikma Pharmaceuticals USA Inc.	436f5616-9626-4b6a-9deb-2986444179d0	2024-06-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527 ndc (product): 0143-9683 ndc (product): 0143-9684
Flumazenil	FLUMAZENIL	A-S Medication Solutions	2190e8d0-d7ca-4f53-b243-0d2c31979aa8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527 ndc (product): 50090-1337
Flumazenil	FLUMAZENIL	Hikma Pharmaceuticals USA Inc.	442ed32b-b508-40cc-9915-ff05674566da	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527 ndc (product): 0143-9784 ndc (product): 0143-9783
FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA Health First	744ef484-ef46-8d62-e053-2a91aa0a0c05	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527 ndc (product): 51662-1253
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	6673efde-057a-a889-e053-2a91aa0a517b	2023-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527 ndc (product): 71872-7038
Flumazenil	FLUMAZENIL	Medical Purchasing Solutions, LLC	6671d89f-cc82-c03c-e053-2a91aa0aa5fa	2022-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078527 application number: ANDA078527 ndc (product): 71872-7008

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9683	Flumazenil	Flumazenil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9683	Flumazenil	Flumazenil	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9684	Flumazenil	Flumazenil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9684	Flumazenil	Flumazenil	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9783	Flumazenil	flumazenil	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9784	Flumazenil	flumazenil	West-Ward Pharmaceuticals Corp	ANDA	Current
50090-1337	Flumazenil	flumazenil	A-S Medication Solutions	ANDA	Current
50090-1337	Flumazenil	flumazenil	A-S Medication Solutions	ANDA	Current
51662-1253	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1253	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1253	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1253	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA Health First	ANDA	Current
51662-1254	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1254	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1254	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
51662-1254	FLUMAZENIL	FLUMAZENIL	HF Acquisition Co. LLC, DBA HealthFirst	ANDA	Current
52584-783	Flumazenil	Flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
52584-783	Flumazenil	Flumazenil	General Injectables and Vaccines, Inc.	ANDA	Current
52584-784	Flumazenil	Flumazenil	General Injectables and Vaccines, Inc	ANDA	Current
52584-784	Flumazenil	Flumazenil	General Injectables and Vaccines, Inc	ANDA	Current
55154-7474	Flumazenil	flumazenil	Cardinal Health	ANDA	Current
70385-2002	Flumazenil	flumazenil	Sina Health Inc	ANDA	Current
70385-2021	Flumazenil	flumazenil	Sina Health Inc	ANDA	Current
71872-7008	Flumazenil	flumazenil	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7008	Flumazenil	flumazenil	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7008	Flumazenil	flumazenil	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7038	Flumazenil	flumazenil	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7038	Flumazenil	flumazenil	Medical Purchasing Solutions, LLC	ANDA	Current