FDA.reportPublic FDA data

Application 065332

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFDINIRCEFDINIRFOR SUSPENSION;ORAL125MG/5MLNoNo
002CEFDINIRCEFDINIRFOR SUSPENSION;ORAL250MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-4136CefdinirCefdinirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4136CefdinirCefdinirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4136CefdinirCefdinirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4136CefdinirCefdinirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4137CefdinirCefdinirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4137CefdinirCefdinirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4137CefdinirCefdinirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-4137CefdinirCefdinirTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-1028CefdinirCefdinirA-S Medication SolutionsANDACurrent
53217-406CefdinirCefdinirAidarex Pharmaceuticals LLCANDACurrent
63187-616CefdinirCefdinirProficient Rx LPANDACurrent
63187-616CefdinirCefdinirProficient Rx LPANDACurrent
63187-616CefdinirCefdinirProficient Rx LPANDACurrent
68071-1788CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1788CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3156CefdinirCefdinirNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3156CefdinirCefdinirNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3156CefdinirCefdinirNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3295CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3295CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2076CefdinirCefdinirREMEDYREPACK INC.ANDACurrent
76519-1172CEFDINIRCEFDINIRH.J. Harkins Company, Inc.ANDACurrent
76519-1214CEFDINIRCEFDINIRH.J. Harkins Company, Inc.ANDACurrent