Application 022308

Type: NDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BESIVANCE	BESIFLOXACIN HYDROCHLORIDE	SUSPENSION/DROPS;OPHTHALMIC	EQ 0.6% BASE	Yes	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
N022308-001	BESIVANCE	BESIFLOXACIN HYDROCHLORIDE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	2009-05-28

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022308-001	8937062	2029-11-13	U-80		2015-02-03
N022308-001	8604020	2030-03-12		Drug product	2013-12-16
N022308-001	8415342	2030-11-07	U-80		2013-04-11
N022308-001	8481526	2031-01-09		Drug substance	2013-07-19

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022308-001	BESIVANCE	EQ 0.6% BASE	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-05-28	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	8937062	2029-11-13	U-80		2015-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	8604020	2030-03-12		Drug product	2013-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	8415342	2030-11-07	U-80		2013-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022308-001	8481526	2031-01-09		Drug substance	2013-07-19	`5bbf6a4d5a75…`

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
Besivance	BESIFLOXACIN	Sportpharm LLC	f312ddb2-3173-4c2c-bf1b-4ade8fb75d94	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022308 application number: NDA022308
Besivance	BESIFLOXACIN	Sportpharm LLC	80bf4981-4f86-4d25-83a5-7d5dfe0b22e0	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022308 application number: NDA022308
Besivance	BESIFLOXACIN	Bausch & Lomb Americas Inc.	ff971287-5610-4f15-8392-fc974e6ff646	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022308 application number: NDA022308
Besivance	BESIFLOXACIN	Bausch & Lomb Incorporated	a3e6d688-7e5e-4ca3-b27e-79756c322a32	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022308 application number: NDA022308 ndc (product): 24208-446

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24208-446	Besivance	Besifloxacin	Bausch & Lomb Incorporated	NDA	Current
24208-446	Besivance	Besifloxacin	Bausch & Lomb Incorporated	NDA	Current
24208-446	Besivance	Besifloxacin	Bausch & Lomb Incorporated	NDA	Current
24208-446	Besivance	Besifloxacin	Bausch & Lomb Incorporated	NDA	Current
50090-1241	Besivance	Besifloxacin	A-S Medication Solutions	NDA	Current
50090-1241	Besivance	Besifloxacin	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53612	SUPPL	2018-04-05
53611	SUPPL	2018-04-05
29567	SUPPL	2012-09-24
38547	SUPPL	2012-09-20
44734	ORIG	2009-07-10
42486	ORIG	2009-07-10
38546	ORIG	2009-06-04
7211	ORIG	2009-06-02
53195	ORIG	1900-01-01
53194	ORIG	1900-01-01
53193	ORIG	1900-01-01