FDA.reportPublic FDA data

Application 090378

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

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 42.

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
A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-09
A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-05-09

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-05-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-05-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-05-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-05-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-05-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-05-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090378-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-05-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090378-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-05-09bb7c543d1eb4…

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 14 · 269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252026-08-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2026-08-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
QUZYTTIRCETIRIZINE HYDROCHLORIDEESTEVE PHARMACEUTICALS, S.A.573770f6-b76e-f6ba-e063-6294a90aa54d2026-07-31Warnings, Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC0b0190c7-acfd-4140-bcaf-9fe835ebaf492026-07-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Incb9ac489a-80ed-4077-b68e-d03df1b892a62026-07-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
allergy reliefCETIRIZINE HYDROCHLORIDEH E B8649fc1e-ad56-4660-bbbb-8f1ed795697b2026-07-20WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEKROGER COMPANYb92d959d-dd35-b2a3-e053-2995a90af3ff2026-07-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochloride - HIVESCETIRIZINE HYDROCHLORIDEGranules Pharmaceuticals Inc.562b5e6c-6103-df3d-e063-6394a90a897d2026-07-14WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEGranules India Ltd6efd5a60-e281-43f9-a52c-a95f46fbcbfc2026-07-14WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.67207357-5f8a-4424-9901-d2717a43cf1b2026-07-14WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDESelect Consumer Group568960cf-2c8f-f1b0-e063-6294a90aebc72026-07-13WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)CETIRIZINE HYDROCHLORIDEMARKSANS PHARMA LIMITED652b0c65-a3f2-4454-9cf2-51a3389282cc2026-07-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyf2f42f36-6b09-4140-e053-2a95a90af8132026-06-29WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Equate Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb73950f4-af6f-4dc7-bce2-9ec43c45eee52026-06-12WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.30cbaa91-2216-efd2-e063-6294a90aaaed2026-06-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEOHM LABORATORIES INC.97802669-b4bd-4807-b3c1-6c6f5a2b0c672026-06-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEFirst Nation Group, LLC5267f7c0-e62f-35da-e063-6394a90a93462026-06-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDESavings Distributors LLC5490c38a-91d7-9ee1-e063-6394a90a1ea52026-06-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE