FDA.reportPublic FDA data

Application 090750

Type
ANDA
Sponsor
AUROBINDO PHARMA

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
A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2010-02-02
A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2010-02-02

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 UTC2022-10A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2010-02-02f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2010-02-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2010-02-02e64feba35796…
2022-09-29 23:25 UTC2022-09A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2010-02-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2010-02-02cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2010-02-02cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02a50c72e98297…

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
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEFred's, Inc.55e799b2-e325-4286-aa9a-b88e99ab11462020-12-13WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
ndc (product): 55315-354
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEC.D.M.A., Inc.b4feed95-86ca-411c-99b5-773e485e752f2020-12-13WarningsExact identifier
application applno (ANDA): 090750
application number: ANDA090750
ndc (product): 63868-865

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 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55315-354CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideFred's, Inc.ANDACurrent
55315-354CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideFred's, Inc.ANDACurrent
55315-354CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideFred's, Inc.ANDACurrent
58602-028Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-028Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-028Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-028Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-030Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-030Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-030Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-030Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-422Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-422Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-422Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-422Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-424Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-424Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-424Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-424Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
63868-865CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideC.D.M.A., Inc.ANDACurrent
63868-865CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideC.D.M.A., Inc.ANDACurrent
63868-865CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideC.D.M.A., Inc.ANDACurrent
63868-865CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideC.D.M.A., Inc.ANDACurrent
65862-422Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-443Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurobindo Pharma LimitedANDACurrent