FDA.reportPublic FDA data

Application 078427

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33992-0128All Day Allergy ReliefCetirizine HClASSURED (Greenbrier International, Inc.)ANDACurrent
53187-220All Day AllergyCetirizine HClLIVE BETTER (The Great Atlantic & Pacific Tea Company)ANDACurrent
55910-220All Day Allergy ReliefCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-221Allergy ReliefCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
59726-220All Day AllergyCetirizine HClP and L Development of New York CorporationANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31366ORIG2008-01-09
18481ORIG2008-01-08