Application 022288

Type
NDA
Sponsor
BAUSCH AND LOMB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BEPREVEBEPOTASTINE BESILATESOLUTION/DROPS;OPHTHALMIC1.5%YesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022288-001BEPREVEBEPOTASTINE BESILATE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022288-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-0884e616aacf4f…
2026-08-18 06:07:402026-07N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICRLD, RS2009-09-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICRLD, RS2009-09-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICRLD, RS2009-09-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICRLD, RS2009-09-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-083f01610625f2…
2019-09-15 20:21 UTC2019-09N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N022288-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N022288-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022288-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022288-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022288-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022288-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022288-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022288-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022288-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022288-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022288-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022288-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022288-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022288-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022288-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022288-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022288-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022288-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022288-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022288-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022288-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022288-001AT1782e0a99824c…
2019-12-14 00:12 UTC2019-12N022288-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N022288-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022288-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022288-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022288-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022288-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022288-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022288-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022288-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022288-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022288-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022288-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022288-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022288-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022288-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022288-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022288-001AT1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022288-00187847892025-01-13Drug product2014-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N022288-00187847892025-01-13Drug product2014-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022288-00187847892025-01-13Drug product2014-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022288-00187847892025-01-13Drug product2014-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022288-00187847892025-01-13Drug product2014-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022288-00187847892025-01-13Drug product2014-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022288-00187847892025-01-13Drug product2014-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022288-00187847892025-01-13Drug product2014-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022288-00187847892025-01-13Drug product2014-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022288-00187847892025-01-13Drug product2014-07-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022288-00187847892025-01-13Drug product2014-07-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022288-00187847892025-01-13Drug product2014-07-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022288-00187847892025-01-13Drug product2014-07-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022288-00188771682023-07-30Drug product2014-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022288-00187847892025-01-13Drug product2014-07-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022288-00188771682023-07-30Drug product2014-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022288-00187847892025-01-13Drug product2014-07-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022288-00188771682023-07-30Drug product2014-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022288-00187847892025-01-13Drug product2014-07-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022288-00167808772019-09-19Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022288-00188771682023-07-30Drug product2014-11-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022288-00187847892024-09-05Drug product2014-07-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022288-00188771682023-07-30Drug product2014-11-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022288-00187847892025-01-13Drug product2014-07-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022288-00188771682023-07-30Drug product2014-11-25782e0a99824c…
2021-12-28 21:50 UTC2021-12N022288-00187847892025-01-13Drug product2014-07-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022288-00188771682023-07-30Drug product2014-11-2587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022288-00187847892025-01-13Drug product2014-07-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N022288-00188771682023-07-30Drug product2014-11-255aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022288-00187847892025-01-13Drug product2014-07-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022288-00188771682023-07-30Drug product2014-11-258869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022288-00187847892025-01-13Drug product2014-07-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022288-00188771682023-07-30Drug product2014-11-25c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022288-00187847892025-01-13Drug product2014-07-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022288-00167808772019-09-19Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022288-00188771682023-07-30Drug product2014-11-253f01610625f2…
2019-12-14 00:12 UTC2019-12N022288-00187847892024-09-05Drug product2014-07-223f01610625f2…
2019-09-15 20:21 UTC2019-09N022288-00167808772019-09-19Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022288-00188771682023-07-30Drug product2014-11-25b00525d2431f…
2019-09-15 20:21 UTC2019-09N022288-00187847892024-09-05Drug product2014-07-22b00525d2431f…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bepotastine BesilateBEPOTASTINE BESILATEBausch & Lomb Americas Inc.70430ab5-cd0a-451e-acab-347a2f9818982024-08-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 022288
application number: NDA022288
ndc (product): 82260-630
BepreveBEPOTASTINE BESILATEBausch & Lomb Incorporated68bbf6a0-c4b5-47c1-8a1c-08220fbdbce62022-08-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 022288
application number: NDA022288
ndc (product): 24208-629
Bepotastine BesilateBEPOTASTINE BESILATEBausch & Lomb Incorporated995f4fe0-d861-4137-8090-a8ffc71c46f42020-12-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 022288
application number: NDA022288
ndc (product): 24208-630

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-630Bepotastine Besilatebepotastine besilateBausch & Lomb IncorporatedNDA AUTHORIZED GENERICCurrent
82260-630Bepotastine Besilatebepotastine besilateBausch & Lomb Americas Inc.NDA AUTHORIZED GENERICCurrent
82260-630Bepotastine Besilatebepotastine besilateBausch & Lomb Americas Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52547SUPPL2018-02-09
52530SUPPL2018-02-09
38516SUPPL2012-06-29
7183SUPPL2012-06-29
44726ORIG2009-10-21
42480ORIG2009-10-21
17205ORIG2009-09-18
7182ORIG2009-09-16
53192ORIG1900-01-01
53191ORIG1900-01-01
53190ORIG1900-01-01