FDA.reportPublic FDA data

Application 090183

Type
ANDA
Sponsor
RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo
002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-24
A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-24

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090183-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A090183-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-24782e0a99824c…

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 3 of 14 · 268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Cetirizine Hydrochloride AllergyCETIRIZINE HYDROCHLORIDEAurohealth LLC4de4f544-79cd-4a89-aafb-f2e2688b3c812026-03-09WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvagen Pharma Ltd.,0956baea-f0ad-4aac-9464-831840db92302026-03-06Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
QUZYTTIRCETIRIZINE HYDROCHLORIDETerSera Therapeutics LLCf33e859d-ebc9-4d4f-a57d-204c48760d202026-03-04Warnings, Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCffbca2a4-8df0-4c85-adf9-9414cd706fb22026-02-26WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
BERKLEY AND JENSEN ALL DAY ALLERGYCETIRIZINE HYDROCHLORIDEBJWCb38c0068-5b06-4976-b68d-617bcc14f0512026-02-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESportpharm LLCdd50d2e9-3de7-4c44-96ed-39ef04dae7022026-02-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEWALMART INC.473ad691-2499-a706-e063-6394a90a97812026-01-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutionsae02b16b-77dc-4bd6-8c07-e734fb4484922026-01-29WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutions158d3bcc-6a7f-4ee7-b181-be3fd6f94f8d2026-01-29WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEStrategic Sourcing Services LLC54509525-ad99-4165-a571-47ece058e2922026-01-29WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CetirizineCETIRIZINE HYDROCHLORIDEMajor Pharmaceuticalsa5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a32026-01-29WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a462f9c0-45ef-49b1-b0d8-a02a75a4b7312026-01-27WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEProdose, Ince0e5f482-0282-410c-8c40-0a33ca4ea23a2026-01-26WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLCee8695ac-1293-4e43-ac7c-a64e21a0ca0a2026-01-19WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Exchange select all day allergyCETIRIZINE HYDROCHLORIDEArmy & Air Force Exchange Servicee7220494-3640-4b33-b577-ed3ca7c483e82026-01-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.efabbad5-a162-45c8-a896-5af58e5d2d392026-01-13Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEWALGREEN CO.9e728bf2-0cb9-ecf5-e053-2a95a90a408a2026-01-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEL. Perrigo Company2a7a27ab-1b4c-40d1-98bf-e4297aa256822026-01-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CetirizineCETIRIZINE HYDROCHLORIDENorthwind Health Company, LLCf2b4d221-30ae-5a43-e053-2995a90a238a2026-01-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride Tablets,10 mgCETIRIZINE HYDROCHLORIDENorthwind Health Company, LLCf756d3b1-d2e4-3705-e053-6294a90aa3802026-01-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE