FDA.reportPublic FDA data

Application 065428

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFPROZILCEFPROZILTABLET;ORAL250MGNoNo
002CEFPROZILCEFPROZILTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-712CEFPROZILCEFPROZILWockhardt LimitedANDACurrent
55648-713CEFPROZILCEFPROZILWockhardt LimitedANDACurrent
64679-712CEFPROZILCEFPROZILWockhardt USA LLC.ANDACurrent
64679-712CEFPROZILCEFPROZILWockhardt USA LLC.ANDACurrent
64679-713CEFPROZILCEFPROZILWockhardt USA LLC.ANDACurrent
64679-713CEFPROZILCEFPROZILWockhardt USA LLC.ANDACurrent