FDA.reportPublic FDA data

Application 078692

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL5MGNoNo
002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL10MGNoYes

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
A078692-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORAL2008-02-14
A078692-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORALRS2008-02-14

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A078692-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2008-02-14f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078692-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORALRS2008-02-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078692-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2008-02-14e64feba35796…
2022-09-29 23:25 UTC2022-09A078692-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORALRS2008-02-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078692-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2008-02-14cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078692-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORALRS2008-02-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078692-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2008-02-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078692-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORALRS2008-02-14a50c72e98297…

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inca814a06b-96ed-4403-bbd7-fc1142988b502025-06-30WarningsExact identifier
application applno (ANDA): 078692
application number: ANDA078692
ndc (product): 0781-5284
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESandoz Inc817d07cf-5e31-421f-9e95-943bae01f5b02025-06-30WarningsExact identifier
application applno (ANDA): 078692
application number: ANDA078692
ndc (product): 0781-5283

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5283Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-5283Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-5284Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0781-5284Cetirizine HydrochlorideCetirizine HydrochlorideSandoz IncANDACurrent
0904-5879Cetirizine HydrochlorideCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
11822-0578Childrens Allergy ReliefCetirizine HClRite Aid CorporationANDACurrent
49035-578Childrens Allergy ReliefCetirizine HClWal-Mart Stores IncANDACurrent
50844-578Childrens Allergy ReliefCetirizine HClL.N.K. International, Inc.ANDACurrent
50844-578Childrens Allergy ReliefCetirizine HClL.N.K. International, Inc.ANDACurrent
50844-578Childrens Allergy ReliefCetirizine HClL.N.K. International, Inc.ANDACurrent
59779-978Allergy ReliefCetirizine HClCVS PharmacyANDACurrent