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 5 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES ALL-DAY Allergy ReliefCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8227edbe-88d5-4d79-9175-891dd95663572025-11-20WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
GOODNOW ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEGobrands, Inc86ade508-8841-47d8-addb-418ecd6dc8de2025-11-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.5481ccb3-b311-4b25-b923-4fe8522ea92b2025-11-05WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEVERITYRX, LLC42a1168e-e2cd-a1e5-e063-6294a90ab3b62025-11-02WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBluePoint Laboratoriesa86fbe45-08db-bddf-e053-2a95a90aa7922025-10-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CetirizineCETIRIZINE HYDROCHLORIDEVERITYRX, LLC43f40b92-f0e0-8808-e063-6394a90a656b2025-10-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CetirizineCETIRIZINE HYDROCHLORIDEA-S Medication Solutions88c3d23e-a0d8-4464-9414-666d74f11f662025-10-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEBionpharma Inc.41d7af88-87b4-370e-e063-6294a90a8af62025-10-24Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ValuMeds All Day Allergy Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.3071238a-6b35-4da8-8305-eced56c513ce2025-10-23WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ZYRTEC AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC0face45c-af24-3559-e063-6294a90abde52025-10-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC05324e41-ee3f-0e4b-e063-6294a90a102c2025-10-16Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLCb165db38-b302-4220-8627-77cb07bb078c2025-10-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLC9d8e78ea-af98-4f7c-8db5-044b49582f802025-10-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC6685a843-9dbe-4f9e-b75b-fe0e258f41552025-10-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.06cdcbe0-6c7c-4b91-8158-08ef2e0876dc2025-10-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.c6f08e78-10fc-48d0-a3e1-e227081548eb2025-10-07WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAventura Pharmaceuticals, LLCaeb73ab9-3b05-4062-a7fd-352cf2094a562025-10-02Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMarlex Pharmaceuticals, Inceb917099-fecf-6b55-e053-2995a90aaafa2025-09-23WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
allergy reliefCETIRIZINE HYDROCHLORIDESafewayc5e74b2c-7871-4f28-a77d-0d674b9b8c5e2025-09-23WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CVS Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECVS Pharmacy3d711302-dc4e-0a69-e063-6394a90ade102025-09-18WarningsName 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