Application 206911

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BROMSITE	BROMFENAC SODIUM	SOLUTION/DROPS;OPHTHALMIC	EQ 0.075% ACID	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
N206911-001	BROMSITE	BROMFENAC SODIUM	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N206911-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206911-001	RE50218	2029-03-05	U-1834	Drug product	2024-12-26

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2016-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206911-001	BROMSITE	EQ 0.075% ACID	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206911-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206911-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206911-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206911-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206911-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206911-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206911-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206911-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206911-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206911-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206911-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206911-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206911-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206911-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206911-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206911-001	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206911-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206911-001	RE50218	2029-03-05	U-1834	Drug product	2024-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206911-001	RE50218	2029-03-05	U-1834	Drug product	2024-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206911-001	RE50218	2029-03-05	U-1834	Drug product	2024-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206911-001	RE50218	2029-03-05	U-1834	Drug product	2024-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206911-001	RE50218	2029-03-05	U-1834	Drug product	2024-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206911-001	RE50218	2029-03-05	U-1834	Drug product	2024-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206911-001	8778999	2029-08-07	U-1834	Drug product	2016-05-05	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N206911-001	NP	2019-04-08	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N206911-001	NP	2019-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206911-001	NP	2019-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206911-001	NP	2019-04-08	`ea99ee380514…`

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
BROMSITE 0.075%	BROMFENAC	Sun Pharmaceutical Industries, Inc.	144a5072-341b-4591-8705-773b63044bcc	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206911 application number: NDA206911 ndc (product): 49708-754
bromfenac 0.075%	BROMFENAC	Sun Pharmaceutical Industries, Inc.	7d723a00-4822-4e04-aa22-21de22009d0a	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206911 application number: NDA206911

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49708-754	BromSite	bromfenac	Sun Pharmaceutical Industries, Inc.	NDA	Current
49708-754	BROMSITE	bromfenac	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73730	SUPPL	2023-04-25
73724	SUPPL	2023-03-10
52885	ORIG	2018-03-09
40573	ORIG	2016-04-13
32834	ORIG	2016-04-12