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 6 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline all day allergyCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI491fae66-83b6-4beb-945b-39b9e4e021c52025-09-18WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc0827643a-29b8-487a-a158-28976d672d4d2025-09-12WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ALLERGYCETIRIZINE HYDROCHLORIDEKroger Companybc020340-ef39-e49a-e053-2a95a90af8102025-09-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e2025-08-31Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company533abfc1-226e-4a68-bfcc-ec046a4d57512025-08-25WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.6d81446e-f713-4ca4-af38-3d31cf6188732025-08-01Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC3b5908f1-faba-c317-e063-6294a90aa8a72025-08-01Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC2c1ecee3-c2c1-25a2-e063-6294a90aad542025-07-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
good neighbor pharmacy all day allergyCETIRIZINE HYDROCHLORIDEAmerisource Bergenc568e388-60ab-47be-b362-7832b83d06ad2025-07-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
leader all day allergyCETIRIZINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf2025-07-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMylan Institutional Inc.bd0dc7f6-5fb9-4381-bd81-b150b75a2c682025-07-18WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEDiscount Drug Mart, Incc7c7e496-3682-c764-88ef-d2a09823f71e2025-07-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
childrens allergyCETIRIZINE HYDROCHLORIDEPublix Super Markets Incae216d0b-8ccc-4cc4-82f4-4d0f3a2568222025-07-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Premier Value Childrens CetirizineCETIRIZINE HYDROCHLORIDEPharmacy Value Alliance LLCa4931f0b-86f2-42c5-b2df-b359bb46f44a2025-07-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Inc2b03c026-3e8a-4283-981f-965bc084c03d2025-07-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC601c2846-30e7-40f1-96b4-64fbed719c0b2025-07-10WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cabinet Allergy Relief Refill Cetirizine HCICETIRIZINE HYDROCHLORIDECabinet Health P.B.C.0eaf9d27-e221-4cdd-97bc-478c775e3d672025-07-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.54d72d7a-1f5b-4b36-bf76-ab7aef6243ab2025-07-02WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inca814a06b-96ed-4403-bbd7-fc1142988b502025-06-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inc817d07cf-5e31-421f-9e95-943bae01f5b02025-06-30WarningsName 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