FDA.reportPublic FDA data

Application 210914

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-659levocetirizine dihydrochloridelevocetirizine dihydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
68071-2836levocetirizine dihydrochloridelevocetirizine dihydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent