FDA.reportPublic FDA data

Application 078317

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078317-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078317-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A078317-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27e64feba35796…
2022-09-29 23:25 UTC2022-09A078317-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078317-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078317-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078317-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078317-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HCL 10 MGAllegiant Health96952314-fd4c-455f-b55e-645c19d6e3662018-12-31WarningsExact identifier
application applno (ANDA): 078317
application number: ANDA078317
ndc (product): 69168-392

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 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-1024Wal-ZyrWal-ZyrWalgreen CompanyANDACurrent
0363-1024Wal-ZyrWal-ZyrWalgreen CompanyANDACurrent
0536-1041Cetirizine HydrochlorideCetirizine HydrochlorideRugby LaboratoriesANDACurrent
0536-1041Cetirizine HydrochlorideCetirizine HydrochlorideRugby LaboratoriesANDACurrent
0904-5852CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-5852CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-5852Cetirizine HydrochlorideCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-5852Cetirizine HydrochlorideCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
11822-6053CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERite Aid CorporationANDACurrent
11822-6053CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERite Aid CorporationANDACurrent
11822-6059CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERite Aid CorporationANDACurrent
11822-6059CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERite Aid CorporationANDACurrent
11822-7053CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERite Aid CorporationANDACurrent
11822-7053CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDERite Aid CorporationANDACurrent
33992-3962Allergy ReliefCetirizine HCl 10 mgGreenbrier InternationalANDACurrent
50066-310Allergy ReliefCetirizine HCl 10 mgGenomma Labs USA, IncANDACurrent
50066-310Allergy ReliefCetirizine HCl 10 mgGenomma Labs USA, IncANDACurrent
50066-396Allergy ReliefCetirizine HCl 10 mgGenomma Labs USA, IncANDACurrent
50066-396Allergy ReliefCetirizine HCl 10 mgGenomma Labs USA, IncANDACurrent
50090-3188Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3188Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
60505-2632Cetirizine HydrochlorideCetirizine HydrochlorideApotex Corp.ANDACurrent
60505-2632Cetirizine HydrochlorideCetirizine HydrochlorideApotex Corp.ANDACurrent
60505-2633Cetirizine HydrochlorideCetirizine HydrochlorideApotex Corp.ANDACurrent
60505-2633Cetirizine HydrochlorideCetirizine HydrochlorideApotex Corp.ANDACurrent
60505-4650CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEApotex Corp.ANDACurrent
60505-4650CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEApotex Corp.ANDACurrent
60687-165Cetirizine HydrochlorideCetirizine HydrochlorideAmerican Health PackagingANDACurrent
63187-932Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
63187-932Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent
63629-5153Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
63629-5153Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
68071-1988Cetirizine HydrochlorideCetirizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1988Cetirizine HydrochlorideCetirizine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
69168-310Allergy ReliefCetirizine HCl 10 mgAllegiant HealthANDACurrent
69168-310Allergy ReliefCetirizine HCl 10 mgAllegiant HealthANDACurrent
69168-392Allergy ReliefCetirizine HCl 10 mgAllegiant HealthANDACurrent
70518-0910Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0910Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1989Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1989Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1989Cetirizine HydrochlorideCetirizine HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0755Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0755Cetirizine HydrochlorideCetirizine HydrochlorideBryant Ranch PrepackANDACurrent
71610-048CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-093Cetirizine HydrochlorideCetirizine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31355ORIG2008-01-09
18479ORIG2008-01-08