FDA.reportPublic FDA data

Application 077847

Type
ANDA
Sponsor
HI TECH PHARMA

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 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
A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2008-10-28

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 UTC2022-10A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2008-10-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2008-10-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMICAT2008-10-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2008-10-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077847-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077847-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077847-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077847-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077847-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077847-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077847-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A077847-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077847-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077847-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077847-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A077847-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077847-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077847-001AT116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077847-001AT111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077847-001AT11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077847-001AT11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077847-001AT119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077847-001AT11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077847-001AT113f0d92c62455…
2023-05-13 08:27 UTC2023-05A077847-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077847-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077847-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077847-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077847-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077847-001AT1cb3db0bc1861…

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1247Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateA-S Medication SolutionsANDACurrent
50090-1247Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateA-S Medication SolutionsANDACurrent
50090-1247Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateA-S Medication SolutionsANDACurrent
50090-1247Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateA-S Medication SolutionsANDACurrent
50090-1247Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateA-S Medication SolutionsANDACurrent
50383-233Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-233Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-233Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-233Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateAkornANDACurrent
50383-233Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-233Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateHi-Tech Pharmacal Co., Inc.ANDACurrent
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateGolden State Medical Supply, Inc.ANDACurrent
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateGolden State Medical Supply, Inc.ANDACurrent
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateGolden State Medical Supply, Inc.ANDACurrent
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateGolden State Medical SupplyANDACurrent
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateGolden State Medical SupplyANDACurrent
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateGolden State Medical Supply, Inc.ANDACurrent
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateGolden State Medical Supply, Inc.ANDACurrent
60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol MaleateGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31293ORIG2008-11-03