FDA.reportPublic FDA data

Application 065276

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFPROZILCEFPROZILTABLET;ORAL250MGNoNo
002CEFPROZILCEFPROZILTABLET;ORAL500MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-842CEFPROZILCEFPROZILPD-Rx Pharmaceuticals, Inc.ANDACurrent
52959-300CEFPROZILCEFPROZILH. J. Harkins Company, Inc.ANDACurrent
53217-031CEFPROZILCEFPROZILAidarex Pharmaceuticals LLCANDACurrent
57297-403CEFPROZILCEFPROZILLUPIN LIMITEDANDACurrent
57297-404CEFPROZILCEFPROZILLUPIN LIMITEDANDACurrent
67296-0590CEFPROZILCEFPROZILRedPharm Drug Inc.ANDACurrent
68180-403CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.ANDACurrent
68180-403CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.ANDACurrent
68180-403CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.ANDACurrent
68180-403CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.ANDACurrent
68180-404CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.ANDACurrent
68180-404CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.ANDACurrent
68180-404CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.ANDACurrent
68180-404CEFPROZILCEFPROZILLupin Pharmaceuticals, Inc.ANDACurrent