FDA.reportPublic FDA data

Application 209406

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRINZOLAMIDEBRINZOLAMIDESUSPENSION/DROPS;OPHTHALMIC1%NoNo

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
A209406-001BRINZOLAMIDEBRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2020-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209406-001AB

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 22:54:322026-06A209406-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2020-11-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209406-001AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRINZOLAMIDEBRINZOLAMIDEOceanside Pharmaceuticals.fb7229d4-522e-4cb2-b513-9d34f3ded5912026-04-20Warnings, Adverse reactionsName fallback
brand name: BRINZOLAMIDE
generic name: BRINZOLAMIDE
BRINZOLAMIDEBRINZOLAMIDEPadagis US LLCb56a2e4b-7502-4831-a5b1-0370bdb987b12024-08-31Warnings, Adverse reactionsName fallback
brand name: BRINZOLAMIDE
generic name: BRINZOLAMIDE
BRINZOLAMIDEBRINZOLAMIDEBausch & Lomb Incorporated37b19837-fcab-4536-abad-6f4f92dfe7942024-07-10Warnings, Adverse reactionsName fallback
brand name: BRINZOLAMIDE
generic name: BRINZOLAMIDE
BRINZOLAMIDEBRINZOLAMIDEBryant Ranch Prepack460baf5f-1d47-4ae0-b635-84507c3b028d2023-12-19Warnings, Adverse reactionsName fallback
brand name: BRINZOLAMIDE
generic name: BRINZOLAMIDE
AzoptBRINZOLAMIDESandoz Inc0afb6589-51ba-432c-aed1-20a12d5d34552023-11-24Warnings, Adverse reactionsName fallback
generic name: BRINZOLAMIDE
BrinzolamideBRINZOLAMIDESandoz Inced6dbc25-47d7-42db-9787-5814d71f45ce2023-06-30Warnings, Adverse reactionsName fallback
brand name: Brinzolamide
generic name: BRINZOLAMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2127BrinzolamideBrinzolamideActavis Pharma, Inc.ANDACurrent
0591-2127BrinzolamideBrinzolamideActavis Pharma, Inc.ANDACurrent
0591-2127BrinzolamideBrinzolamideActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65853ORIG2021-01-07