FDA.reportPublic FDA data

Application 091180

Type
ANDA
Sponsor
ZAMBON SPA

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 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
A091180-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2013-12-04

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 22:54:322026-06A091180-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2013-12-04a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 MALEATEGenus Lifesciences3b3a4716-1082-4a7a-bf5a-2e2bac38dfbc2025-09-08Warnings, 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 MALEATEAurobindo Pharma Limited2d5dcaa5-97ee-40c3-aa29-fcfb91fb78e12024-05-21Warnings, 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