Flumazenil

Product NDC: 55154-7474
11-digit product format: 551547474
Labeler code: 55154
Product ID: 55154-7474_9127d9b0-480c-4287-a0c1-0de39a158f46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: flumazenil
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Cardinal Health
Application: ANDA078527
Marketing category: ANDA
Marketing start: 2007-01-01
Marketing end: 2020-03-31
Substance: FLUMAZENIL
Active strength: 0 mg/mL
Pharmacologic classes: Benzodiazepine Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55154-7474		D	Discontinued by firm		2026-08-17
excluded package	package	55154-7474	55154-7474-8	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-7474-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-7474-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-7474-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-7474-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-7474-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-7474-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-7474-8	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-7474-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-7474-8	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-7474-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55154-7474-8	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55154-7474-8	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUMAZENIL	ACTIVE INGREDIENT	40P7XK9392	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1
FLUMAZENIL	ACTIVE MOIETY	40P7XK9392	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUMAZENIL INJECTION, SOLUTION [CARDINAL HEALTH]	1

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
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
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
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
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
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
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