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

NDC Listings For This Application#

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