FDA.reportPublic FDA data

Application 091034

Type
ANDA
Sponsor
ZAMBON SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 2% 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
A091034-001DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDEEQ 2% 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 22:54:322026-06A091034-001DORZOLAMIDE HYDROCHLORIDEEQ 2% 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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDESagent Pharmaceuticals0246463c-6c24-4611-8e22-2d5254ace66a2026-01-09Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride
generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEFOSUN PHARMA USA INCef173b63-499f-301b-e053-2995a90a47712025-09-26Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride
generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEGland Pharma Limited2023e603-12bb-4502-9f93-0126e0cc24ed2025-05-10Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride
generic name: DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDEAdvagen Pharma Ltd.ed9d1658-43cc-4c78-b3d8-e7d980a6b6732025-02-28Warnings, Adverse reactionsName fallback
brand name: DORZOLAMIDE HYDROCHLORIDE
generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDESomerset Therapeutics, LLC0832960f-0a6f-4fd1-bf55-be9bebde53bd2025-02-12Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride
generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride Ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDEMicro Labs Limited4698e4e1-c5f6-4db1-9328-74464a85afea2025-01-08Warnings, Adverse reactionsName fallback
generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide HydrochlorideDORZOLAMIDEIndoco Remedies Limited462a61b2-1ec6-4d18-bc6b-fc03e027caa02024-10-04Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEAlembic Pharmaceuticals Inc.5ad43fd4-19f0-448f-97a8-625ada4cb1472024-08-27Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride
generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEAlembic Pharmaceuticals Limitedfb2e0729-b0bc-4c3f-9961-8bb38f84a0322024-08-27Warnings, Adverse reactionsName fallback
brand name: Dorzolamide Hydrochloride
generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide hydrochlorideDORZOLAMIDE HYDROCHLORIDELeading Pharma, LLC7d4cb6cd-86d0-41d9-baa9-bca0fa7b06942024-05-24Warnings, Adverse reactionsName fallback
brand name: Dorzolamide hydrochloride
generic name: DORZOLAMIDE HYDROCHLORIDE
Dorzolamide Hydrochloride OphthalmicDORZOLAMIDE HYDROCHLORIDEA-S Medication Solutionsfa4b8802-3271-48a4-8a91-229ebc72f5702023-12-15Warnings, Adverse reactionsName fallback
generic name: DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDESandoz Inc29157995-fa61-4425-86a5-5bd0e4718cd82022-12-20Warnings, Adverse reactionsName fallback
brand name: DORZOLAMIDE HYDROCHLORIDE
generic name: DORZOLAMIDE HYDROCHLORIDE