FDA.reportPublic FDA data

Application 216308

Type
ANDA
Sponsor
NEW HEIGHTSRX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATESOLUTION/DROPS;OPHTHALMICEQ 2% BASE;EQ 0.5% BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A216308-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT22025-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216308-001AT2

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
2026-09-14 22:38:342026-08A216308-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT22025-02-1884e616aacf4f…
2026-08-18 06:07:402026-07A216308-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT22025-02-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216308-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT22025-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216308-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT22025-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A216308-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT22025-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216308-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT22025-02-18fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216308-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT22025-02-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A216308-001AT2184e616aacf4f…
2026-08-18 06:07:402026-07A216308-001AT21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216308-001AT21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216308-001AT2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216308-001AT216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216308-001AT21fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216308-001AT21a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEAurobindo Pharma Limited2d5dcaa5-97ee-40c3-aa29-fcfb91fb78e12026-08-13Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepackff76c0cf-256c-4015-94f4-405f0c46205f2026-05-01Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride and Timolol Maleate
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEMicro Labs Limitedb0a1d984-efee-4751-9797-c09adc2d307d2026-04-30Warnings, Adverse reactionsName fallback
brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEAkorn4e90c721-21e8-46ea-ab49-19f535bf72022025-09-10Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEA-S Medication Solutions8cdf22c8-75ca-404e-b354-9e254690d0e72024-11-01Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride and Timolol Maleate
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATESomerset Therapeutics, LLC17f04726-725f-4839-911d-47fc5e02baae2024-09-18Warnings, Adverse reactionsName fallback
brand name: DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEBryant Ranch Prepackcfdc5577-fe7a-4b51-b2f5-95806e1dee2d2024-08-20Warnings, Adverse reactionsName fallback
brand name: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGland Pharma Limitedefab039e-a69d-4306-8305-b1d27781cfe02024-05-14Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepackbe8b1a47-3342-4072-b67c-6d1374d5d4d62023-12-07Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide hydrochloride and timolol maleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEIngenus Pharmaceuticals, LLC36c0e765-dfda-4b3b-8a98-a5f8b32607f72023-08-02Warnings, Adverse reactionsName fallback
brand name: Dorzolamide hydrochloride and timolol maleate
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBausch & Lomb Incorporated7f6ab3f6-3644-434c-b6cf-e4f111d189622023-06-23Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride and Timolol Maleate
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATESandoz Inc78f39126-3e3b-4633-a4e0-c1f09a794eec2021-05-31Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride and Timolol Maleate

Reported adverse events (FAERS/openFDA)#

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