FDA.reportPublic FDA data

Application 076372

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATESOLUTION/DROPS;OPHTHALMIC0.2%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
A076372-001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMIC2004-09-10

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 22:54:322026-06A076372-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMIC2004-09-10a50c72e98297…

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
brimonidine tartrateBRIMONIDINE TARTRATEMicro Labs Limited981a75cd-2487-40e4-911a-26de2aa98dc12026-05-21Warnings, Adverse reactionsName fallback
brand name: brimonidine tartrate
generic name: BRIMONIDINE TARTRATE
LUMIFY Redness Reliever Eye DropsBRIMONIDINE TARTRATEBausch & Lomb Incorporated022de945-0b26-40ae-8e88-d3fe2464d1062026-03-31WarningsName fallback
generic name: BRIMONIDINE TARTRATE
LUMIFY PRESERVATIVE FREE EYE DROPSBRIMONIDINE TARTRATEBausch & Lomb Incorporatedef5974b9-946c-4983-80e3-32b3aa28c2072026-03-17WarningsName fallback
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATEGland Pharma Limitede4b04ef1-6586-4386-a844-2c5fc3bd4a8f2026-03-12Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATEFlorida Pharmaceutical Products, LLCa25f7abf-e066-4d16-a0ba-6150bdace81d2026-01-28Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATESandoz Incb1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd2025-11-24Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATEApotex Corp.64b21e68-610c-5194-ccb2-9d9f6ff8cda92025-10-08Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
BrimonidineBRIMONIDINE TARTRATESandoz Inc87c5a534-4321-46c7-9938-84dca34b65062025-10-07Warnings, Adverse reactionsName fallback
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATEApotex Corp.e08a915a-77ca-4d16-d760-11b05848418d2025-09-25Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
Brimonidine tartrateBRIMONIDINE TARTRATEPacific Pharma, Inc.5c4aea88-95ca-4da8-a3da-02f10c8b66232025-09-18Warnings, Adverse reactionsName fallback
brand name: Brimonidine tartrate
generic name: BRIMONIDINE TARTRATE
ALPHAGAN PBRIMONIDINE TARTRATEAllergan, Inc.264c4494-c225-486f-888a-caaf36be46b32025-09-18Warnings, Adverse reactionsName fallback
generic name: BRIMONIDINE TARTRATE
Brimonidine tartrateBRIMONIDINE TARTRATEMicro Labs Limited75c5f708-1afb-4505-94a6-a2c0afb0aedc2025-07-24Warnings, Adverse reactionsName fallback
brand name: Brimonidine tartrate
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATESandoz Incdfd85672-fa4b-40e3-ac9c-81b8d9e4ffde2025-05-30Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
BRIMONIDINE TARTRATEBRIMONIDINE TARTRATESomerset Therapeutics, LLCcdb8620f-adfa-4433-b285-9c42334f86002025-03-22Warnings, Adverse reactionsName fallback
brand name: BRIMONIDINE TARTRATE
generic name: BRIMONIDINE TARTRATE
MirvasoBRIMONIDINE TARTRATEGalderma Laboratories, L.P.f6a4353f-ae69-4214-901f-e5d42a6fbde72024-10-24Warnings, Adverse reactionsName fallback
generic name: BRIMONIDINE TARTRATE
BRIMONIDINE TARTRATEBRIMONIDINE TARTRATESomerset Therapeutics, LLCb8e108b3-aca8-4e3e-8577-37ac796148c32024-08-26Warnings, Adverse reactionsName fallback
brand name: BRIMONIDINE TARTRATE
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATEBausch & Lomb Incorporated865f88b0-b13e-4607-a314-939f1b331e6f2024-07-19Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATEAlembic Pharmaceuticals Limitedee26e0c9-a169-4842-ab0f-3c718bb140182023-08-28Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATEAlembic Pharmaceuticals Inc.9da815fb-6454-4925-9150-bec40eff9c2d2023-08-11Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
Brimonidine TartrateBRIMONIDINE TARTRATEIndoco Remedies Limited383421a5-5d33-4f15-88f4-8b66fcbfac712018-12-27Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE