FDA.reportPublic FDA data

Application 216361

Type
ANDA
Sponsor
SLAYBACK PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATESOLUTION;OPHTHALMIC0.025%NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A216361-001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16c2088c7a36db…
2026-09-14 22:38:342026-08A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-1684e616aacf4f…
2026-08-18 06:07:402026-07A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-168072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-166a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216361-001BRIMONIDINE TARTRATE0.025%SOLUTION/DROPS / OPHTHALMIC2024-02-16a50c72e98297…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brimonidine TartrateBRIMONIDINE TARTRATEApotex Corp.e08a915a-77ca-4d16-d760-11b05848418d2026-09-09Warnings, Adverse reactionsName fallback
brand name: Brimonidine Tartrate
generic name: BRIMONIDINE TARTRATE
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
BrimonidineBRIMONIDINE TARTRATESandoz Inc87c5a534-4321-46c7-9938-84dca34b65062025-10-07Warnings, Adverse reactionsName fallback
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
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73414ORIG 2024-03-07