Application 074447

Type: ANDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLURBIPROFEN SODIUM	FLURBIPROFEN SODIUM	SOLUTION/DROPS;OPHTHALMIC	0.03%	No	No

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
A074447-001	FLURBIPROFEN SODIUM	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04

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	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC	AT		1995-01-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074447-001	FLURBIPROFEN SODIUM	0.03%	SOLUTION/DROPS / OPHTHALMIC		RS	1995-01-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074447-001	AT	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A074447-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074447-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074447-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074447-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074447-001	AT	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flurbiprofen Sodium	FLURBIPROFEN SODIUM	Amici Pharma, Inc.	c27f2d57-4b9d-4b78-8d85-3bac84f733b1	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074447 application number: ANDA074447 ndc (product): 69292-722
Flurbiprofen Sodium	FLURBIPROFEN SODIUM	Bausch & Lomb Incorporated	11db354f-caf9-4567-811e-6c9beb1330c7	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074447 application number: ANDA074447 ndc (product): 24208-314
Flurbiprofen Sodium	FLURBIPROFEN SODIUM	A-S Medication Solutions	9243ed05-1f7b-43ee-82c3-572a4112ae09	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074447 application number: ANDA074447 ndc (product): 50090-3946
Flurbiprofen Sodium	FLURBIPROFEN SODIUM	Proficient Rx LP	8c5247a4-6388-44f4-8a47-3de5e7c5b169	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074447 application number: ANDA074447 ndc (product): 63187-937

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-615	Flurbiprofen Sodium	Flurbiprofen Sodium	Rebel Distributors Corp	ANDA	Current
24208-314	Flurbiprofen Sodium	Flurbiprofen Sodium	Bausch & Lomb Incorporated	ANDA	Current
24208-314	Flurbiprofen Sodium	Flurbiprofen Sodium	Bausch & Lomb Incorporated	ANDA	Current
50090-0625	Flurbiprofen Sodium	Flurbiprofen Sodium	A-S Medication Solutions	ANDA	Current
50090-3946	Flurbiprofen Sodium	Flurbiprofen Sodium	A-S Medication Solutions	ANDA	Current
50090-3946	Flurbiprofen Sodium	Flurbiprofen Sodium	A-S Medication Solutions	ANDA	Current
50090-3946	Flurbiprofen Sodium	Flurbiprofen Sodium	A-S Medication Solutions	ANDA	Current
63187-937	Flurbiprofen Sodium	Flurbiprofen Sodium	Proficient Rx LP	ANDA	Current
63187-937	Flurbiprofen Sodium	Flurbiprofen Sodium	Proficient Rx LP	ANDA	Current
69292-722	Flurbiprofen Sodium	Flurbiprofen Sodium	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-722	Flurbiprofen Sodium	Flurbiprofen Sodium	AMICI PHARMACEUTICALS LLC	ANDA	Current
69292-722	Flurbiprofen Sodium	Flurbiprofen Sodium	AMICI PHARMACEUTICALS LLC	ANDA	Current