FDA.reportPublic FDA data

Application 091263

Type
ANDA
Sponsor
L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDESOLUTION;ORAL2.5MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-680levocetirizine dihydrochlorideLevocetirizine dihydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
45802-680levocetirizine dihydrochlorideLevocetirizine dihydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
45802-680levocetirizine dihydrochlorideLevocetirizine dihydrochloridePerrigo New York IncANDACurrent
45802-680levocetirizine dihydrochlorideLevocetirizine dihydrochloridePerrigo New York IncANDACurrent
45802-680levocetirizine dihydrochlorideLevocetirizine dihydrochloridePerrigo New York IncANDACurrent
63629-2533levocetirizine dihydrochlorideLevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent
63629-2533levocetirizine dihydrochlorideLevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent
63629-2533levocetirizine dihydrochlorideLevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9329ORIG2011-11-08