FDA.reportPublic FDA data

Application 079186

Type
ANDA
Sponsor
AM REGENT

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 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
A079186-001DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMIC2009-11-18

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A079186-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMIC2009-11-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079186-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMIC2009-11-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079186-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMIC2009-11-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A079186-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMIC2009-11-18a50c72e98297…

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 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

Reported adverse events (FAERS/openFDA)#

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