Application 021664

Type: NDA
Sponsor: BAUSCH AND LOMB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XIBROM	BROMFENAC SODIUM	SOLUTION/DROPS;OPHTHALMIC	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	BROMDAY	BROMFENAC SODIUM	SOLUTION/DROPS;OPHTHALMIC	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021664-001	XIBROM	BROMFENAC SODIUM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2005-03-24
N021664-002	BROMDAY	BROMFENAC SODIUM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	2010-10-16

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021664-001	XIBROM	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2005-03-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021664-002	BROMDAY	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD	2010-10-16	`3a93d1ddd44b…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bromfenac Ophthalmic Solution, 0.07%	BROMFENAC SODIUM	Apotex Corp.	4246c669-3c2a-2a2b-3b1c-696deb4ab519	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
bromfenac ophthalmic solution	BROMFENAC SODIUM	Bausch & Lomb Americas Inc.	246e2110-6a2d-4e22-8e37-72d80796b9af	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
Prolensa	BROMFENAC SODIUM	Bausch & Lomb Incorporated	4e072537-f73c-4a96-a65f-e2805ce112d8	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
bromfenac ophthalmic solution	BROMFENAC SODIUM	Dr. Reddy's Laboratories Inc.	fa249b9e-931c-454d-ba06-33139d5580e7	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
BROMFENAC SODIUM	BROMFENAC SODIUM	Alembic Pharmaceuticals Inc.	f6911061-d00e-466d-b623-f81730f38f98	2025-04-07	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
bromfenac sodium	BROMFENAC SODIUM	Lupin Pharmaceuticals, Inc.	26f3e5b3-a739-4b09-8046-e71ecb3a5a7b	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM
BROMFENAC SODIUM	BROMFENAC SODIUM	Alembic Pharmaceuticals Limited	f66f1436-daaa-412a-8822-c64866cfeada	2024-07-09	Warnings, Adverse reactions	Name fallback generic name: BROMFENAC SODIUM

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-6301	Bromday	bromfenac	Unit Dose Services	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
15945	SUPPL	2014-01-28
15944	SUPPL	2014-01-28
5948	SUPPL	2014-01-28
5947	SUPPL	2014-01-28
42261	SUPPL	2013-08-09
37425	SUPPL	2010-10-19
5946	SUPPL	2010-10-19
28334	SUPPL	2009-06-08
37424	SUPPL	2009-06-04
42260	ORIG	2007-06-29
28333	SUPPL	2006-01-30
15943	SUPPL	2006-01-27
28332	ORIG	2005-03-29
15942	ORIG	2005-03-29