FDA.reportPublic FDA data

Application 021664

Type
NDA
Sponsor
BAUSCH AND LOMB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XIBROMBROMFENAC SODIUMSOLUTION/DROPS;OPHTHALMICEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002BROMDAYBROMFENAC SODIUMSOLUTION/DROPS;OPHTHALMICEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021664-001XIBROMBROMFENAC SODIUMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24
N021664-002BROMDAYBROMFENAC SODIUMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24e64feba35796…
2022-09-29 23:25 UTC2022-09N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021664-001XIBROMEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2005-03-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021664-002BROMDAYEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD2010-10-16a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bromfenac Ophthalmic Solution, 0.07%BROMFENAC SODIUMApotex Corp.4246c669-3c2a-2a2b-3b1c-696deb4ab5192026-06-15Warnings, Adverse reactionsName fallback
generic name: BROMFENAC SODIUM
bromfenac ophthalmic solutionBROMFENAC SODIUMBausch & Lomb Americas Inc.246e2110-6a2d-4e22-8e37-72d80796b9af2026-05-05Warnings, Adverse reactionsName fallback
generic name: BROMFENAC SODIUM
ProlensaBROMFENAC SODIUMBausch & Lomb Incorporated4e072537-f73c-4a96-a65f-e2805ce112d82026-05-05Warnings, Adverse reactionsName fallback
generic name: BROMFENAC SODIUM
bromfenac ophthalmic solutionBROMFENAC SODIUMDr. Reddy's Laboratories Inc.fa249b9e-931c-454d-ba06-33139d5580e72026-05-05Warnings, Adverse reactionsName fallback
generic name: BROMFENAC SODIUM
BROMFENAC SODIUMBROMFENAC SODIUMAlembic Pharmaceuticals Inc.f6911061-d00e-466d-b623-f81730f38f982025-04-07Warnings, Adverse reactionsName fallback
generic name: BROMFENAC SODIUM
bromfenac sodiumBROMFENAC SODIUMLupin Pharmaceuticals, Inc.26f3e5b3-a739-4b09-8046-e71ecb3a5a7b2025-03-27Warnings, Adverse reactionsName fallback
generic name: BROMFENAC SODIUM
BROMFENAC SODIUMBROMFENAC SODIUMAlembic Pharmaceuticals Limitedf66f1436-daaa-412a-8822-c64866cfeada2024-07-09Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50436-6301BromdaybromfenacUnit Dose ServicesNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
15945SUPPL2014-01-28
15944SUPPL2014-01-28
5948SUPPL2014-01-28
5947SUPPL2014-01-28
42261SUPPL2013-08-09
37425SUPPL2010-10-19
5946SUPPL2010-10-19
28334SUPPL2009-06-08
37424SUPPL2009-06-04
42260ORIG2007-06-29
28333SUPPL2006-01-30
15943SUPPL2006-01-27
28332ORIG2005-03-29
15942ORIG2005-03-29