Application 075989

Type
ANDA
Sponsor
PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATETABLET, EXTENDED RELEASE;ORAL10MG;240MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42507-724allergy and congestion reliefPseudoephedrine sulfate, LoratadineHyVee IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43043ORIG2004-03-04