FDA.reportPublic FDA data

Application 065208

Type
ANDA
Sponsor
TEVA

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
0093-1077CefprozilCefprozilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1077CefprozilCefprozilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1078CefprozilCefprozilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1078CefprozilCefprozilTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-1188CefprozilCefprozilA-S Medication SolutionsANDACurrent
55700-708CefprozilCefprozilQuality Care Products, LLCANDACurrent
55700-708CefprozilCefprozilQuality Care Products, LLCANDACurrent
55700-708CefprozilCefprozilQuality Care Products, LLCANDACurrent
55700-708CefprozilCefprozilQuality Care Products, LLCANDACurrent