Application 022186

Type: NDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AK-FLUOR 10%	FLUORESCEIN SODIUM	INJECTABLE;INTRAVENOUS	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	Yes	No
002	AK-FLUOR 25%	FLUORESCEIN SODIUM	INJECTABLE;INTRAVENOUS	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	Yes	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
N022186-001	AK-FLUOR 10%	FLUORESCEIN SODIUM	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08
N022186-002	AK-FLUOR 25%	FLUORESCEIN SODIUM	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022186-001	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	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022186-001	AK-FLUOR 10%	EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD	2008-08-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022186-002	AK-FLUOR 25%	EQ 500MG BASE/2ML (EQ 250MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-08-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	N022186-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022186-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022186-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022186-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022186-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022186-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022186-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022186-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022186-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022186-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022186-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022186-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022186-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022186-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022186-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022186-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022186-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022186-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022186-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022186-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022186-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022186-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022186-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022186-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022186-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022186-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022186-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022186-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022186-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022186-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022186-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022186-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022186-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022186-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022186-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022186-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022186-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022186-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022186-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022186-001	AP	1	`6a51e52b5d6a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AK-FLUOR	FLUORESCEIN	Long Grove Pharmaceuticals, LLC	73511e79-c050-4dc0-aa2f-a79ed320b5b0	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022186 application number: NDA022186
FLUORESCEIN	FLUORESCEIN	HF Acquisition Co LLC, DBA HealthFirst	c1ffe119-7fba-940f-e053-2a95a90a7a17	2021-08-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022186 application number: NDA022186 ndc (product): 51662-1533

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-250	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-250	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-250	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-250	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-250	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-250	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-253	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-253	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-253	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-253	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-253	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
17478-253	AK-FLUOR	fluorescein sodium	Akorn	NDA	Current
50090-4535	AK-FLUOR	fluorescein sodium	A-S Medication Solutions	NDA	Current
50090-4535	AK-FLUOR	fluorescein sodium	A-S Medication Solutions	NDA	Current
51662-1533	FLUORESCEIN	FLUORESCEIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1533	FLUORESCEIN	FLUORESCEIN	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85529	SUPPL	2026-03-25
85528	SUPPL	2026-03-25
81416	SUPPL	2025-03-04
81415	SUPPL	2025-03-04
44696	ORIG	2009-08-26
42440	ORIG	2009-08-26
29372	ORIG	2008-08-13