FDA.reportPublic FDA data

Application 090765

Type
ANDA
Sponsor
AMNEAL PHARMS

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 44.

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
A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-10-07
A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-10-07

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-07c2088c7a36db…
2026-10-15 13:18:302026-09A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-07c2088c7a36db…
2026-09-14 22:38:342026-08A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-0784e616aacf4f…
2026-09-14 22:38:342026-08A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-0784e616aacf4f…
2026-08-18 06:07:402026-07A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2009-10-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2009-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2009-10-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2009-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2009-10-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2009-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090765-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2009-10-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090765-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2009-10-074b0b4de00fa7…

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 13 · 252 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
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvanced Rx LLC737492bf-96bd-4f7c-aa42-4910746f44bb2025-05-13WarningsName fallback
generic 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
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEFSA STORE INC.ec6b4e86-ac27-e1f2-e053-2a95a90ab3e12025-03-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEUmasuto, LLC9af4ab23-d6d3-43f9-a026-76fd9771963f2025-03-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-003Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-003Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals of New York, LLCANDACurrent
65162-003Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-003Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-005Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-005Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-005Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-005Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals of New York, LLCANDACurrent