Application 019079

Type: NDA
Sponsor: EYEVANCE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLAREX	FLUOROMETHOLONE ACETATE	SUSPENSION/DROPS;OPHTHALMIC	0.1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019079-001	FLAREX	FLUOROMETHOLONE ACETATE	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1986-02-11

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019079-001	FLAREX	0.1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-02-11	`cb3db0bc1861…`

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
Flarex	FLUOROMETHOLONE ACETATE	Harrow Eye, LLC	f060dec4-09dc-4266-ab4c-a6ed49cd8126	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019079 application number: NDA019079
Flarex	FLUOROMETHOLONE ACETATE	Eyevance Pharmaceuticals	19918ea5-8568-44d6-b8ee-7b2197cee85c	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019079 application number: NDA019079 ndc (product): 71776-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0096	Flarex	fluorometholone acetate	Alcon Laboratories, Inc.	NDA	Current
0065-0096	Flarex	fluorometholone acetate	Alcon Laboratories, Inc.	NDA	Current
71776-100	Flarex	fluorometholone acetate	Eyevance Pharmaceuticals	NDA	Current
71776-100	Flarex	fluorometholone acetate	Eyevance Pharmaceuticals	NDA	Current
71776-100	Flarex	fluorometholone acetate	Eyevance Pharmaceuticals	NDA	Current
71776-100	Flarex	fluorometholone acetate	Eyevance Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83490	SUPPL	2025-09-25
83430	SUPPL	2025-09-25
78561	SUPPL	2024-05-28
71717	SUPPL	2022-08-04
71702	SUPPL	2022-08-03
47467	SUPPL	2017-03-06
45726	SUPPL	2016-10-31
16187	SUPPL	2006-11-14
11433	SUPPL	2006-11-09