FDA.reportPublic FDA data

Application 077472

Type
ANDA
Sponsor
RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

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
A077472-001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-18

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-1884e616aacf4f…
2026-08-18 06:07:402026-07A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-183f01610625f2…
2019-09-15 20:21 UTC2019-09A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-06-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077472-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2008-06-18f41ea6bd6efb…

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 7 of 15 · 282 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company533abfc1-226e-4a68-bfcc-ec046a4d57512025-08-25WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
welby allergy reliefCETIRIZINE HYDROCHLORIDEAldi Inccf6b3017-c8b6-4862-aa33-19ed02a43c282025-08-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.6d81446e-f713-4ca4-af38-3d31cf6188732025-08-01Adverse reactionsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC3b5908f1-faba-c317-e063-6294a90aa8a72025-08-01Adverse reactionsName fallback
brand name: CETIRIZINE HYDROCHLORIDE
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC2c1ecee3-c2c1-25a2-e063-6294a90aad542025-07-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
good neighbor pharmacy all day allergyCETIRIZINE HYDROCHLORIDEAmerisource Bergenc568e388-60ab-47be-b362-7832b83d06ad2025-07-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
leader all day allergyCETIRIZINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf2025-07-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMylan Institutional Inc.bd0dc7f6-5fb9-4381-bd81-b150b75a2c682025-07-18WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSDr. Reddy's Laboratories Inc.206ab55a-3720-6205-d710-6e79535714182025-07-17WarningsName fallback
brand name: Cetirizine Hydrochloride
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSStrategic Sourcing Services LLC52b70885-f623-b1c8-29c6-584bff46ed452025-07-17WarningsName fallback
brand name: cetirizine hydrochloride
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEDiscount Drug Mart, Incc7c7e496-3682-c764-88ef-d2a09823f71e2025-07-16WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSDr. Reddy's Laboratories Inc.e4eca4df-9ad8-b7c4-b512-bfaed56737892025-07-16WarningsName fallback
brand name: Cetirizine Hydrochloride
childrens allergyCETIRIZINE HYDROCHLORIDEPublix Super Markets Incae216d0b-8ccc-4cc4-82f4-4d0f3a2568222025-07-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Premier Value Childrens CetirizineCETIRIZINE HYDROCHLORIDEPharmacy Value Alliance LLCa4931f0b-86f2-42c5-b2df-b359bb46f44a2025-07-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Inc2b03c026-3e8a-4283-981f-965bc084c03d2025-07-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC601c2846-30e7-40f1-96b4-64fbed719c0b2025-07-10WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cabinet Allergy Relief Refill Cetirizine HCICETIRIZINE HYDROCHLORIDECabinet Health P.B.C.0eaf9d27-e221-4cdd-97bc-478c775e3d672025-07-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.54d72d7a-1f5b-4b36-bf76-ab7aef6243ab2025-07-02WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inca814a06b-96ed-4403-bbd7-fc1142988b502025-06-30WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inc817d07cf-5e31-421f-9e95-943bae01f5b02025-06-30WarningsName fallback
brand name: Cetirizine Hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31244ORIG2006-11-06