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 8 of 15 · 282 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HYDROCHLORIDEBETTER LIVING BRANDS, LLCeb60ae7d-87db-7413-e053-2a95a90afd762025-06-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEMorning Star OTC3efa421d-ea70-4b1f-95d0-7c63b6c395802025-06-19WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ZYRTEC HivesCETIRIZINE HYDROCHLORIDEKenvue Brands LLC31136e3a-94fa-0860-e063-6394a90a008d2025-06-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ZYRTEC HIVESCETIRIZINE HYDROCHLORIDEKenvue Brands LLC31400cb2-fe85-ef74-e063-6294a90a11fb2025-06-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
kirkland signature aller tec allergyCETIRIZINE HYDROCHLORIDECostco Wholesale Companyd4a688aa-02d4-4af6-9a91-ed31679cfaf82025-06-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackae93976d-de9b-43a6-b299-ce1f1ae8d6f82025-05-21WarningsName fallback
brand name: cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvanced Rx LLC737492bf-96bd-4f7c-aa42-4910746f44bb2025-05-13WarningsName fallback
brand name: Cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBi-Marcbb270c3-34a4-4af8-9da0-2e545787cb552025-05-01WarningsName fallback
brand name: Cetirizine hydrochloride
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINEAmneal Pharmaceuticals LLC365cbabe-535b-4c34-852b-6cd63782e3e52025-05-01Adverse reactionsName fallback
brand name: Cetirizine Hydrochloride
childrens allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company5cdd59a0-4d23-4f51-9aca-d66a639f84722025-04-29WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEINNOVUS PHARMACEUTICALS, INC.89db2c96-62f6-4e75-8f0d-321b44094c602025-04-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
childrens allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company2a62f905-663f-4aae-991f-a368b5120f6f2025-04-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLCa1edc2e6-3661-4d7a-884c-709d73cb89e02025-04-22WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC6a962a1c-c197-492b-bfa6-e0c28eda15332025-04-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEA-S Medication Solutions0adb3617-3528-4d64-a9ad-b4545ec9d7b92025-04-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLC013ce40e-37c9-4b84-b530-ed895f60ce0e2025-04-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cabinet All Day Allergy ReliefCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.889316bc-5f98-426a-9750-2fdb0c4274082025-04-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCe71e259a-494e-4a9a-b0e4-25bd25dd0e072025-04-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEWALGREEN CO.3d2eac7f-db44-4771-8c7e-a38e68a7f24b2025-04-05WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f2025-04-03WarningsName 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