Application 203395

Type: ANDA
Sponsor: HI TECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BROMFENAC SODIUM	BROMFENAC SODIUM	SOLUTION/DROPS;OPHTHALMIC	EQ 0.09% ACID	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203395-001	BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203395-001	AT2

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 · 43 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
2026-09-14 22:38:34	2026-08	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A203395-001	AT2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203395-001	AT2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203395-001	AT2	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bromfenac	BROMFENAC	ARMAS PHARMACEUTICALS INC.	08a0591e-6cb3-30ce-e063-6394a90a33fb	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203395 application number: ANDA203395

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-249	bromfenac	bromfenac	Akorn	ANDA	Current
50383-249	bromfenac	bromfenac	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-249	bromfenac	bromfenac	Hi-Tech Pharmacal Co., Inc.	ANDA	Current