FDA.reportPublic FDA data

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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022288-001BEPREVE1.5%SOLUTION/DROPS / OPHTHALMICATRLD, RS2009-09-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022288-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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