FDA.reportPublic FDA data

Application 065462

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFPODOXIME PROXETILCEFPODOXIME PROXETILTABLET;ORALEQ 100MG BASENoNo
002CEFPODOXIME PROXETILCEFPODOXIME PROXETILTABLET;ORALEQ 200MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5438Cefpodoxime ProxetilCefpodoxime ProxetilSandoz IncANDACurrent
0781-5438Cefpodoxime ProxetilCefpodoxime ProxetilSandoz IncANDACurrent
0781-5438Cefpodoxime ProxetilCefpodoxime ProxetilSandoz IncANDACurrent
0781-5438Cefpodoxime ProxetilCefpodoxime ProxetilSandoz IncANDACurrent
0781-5439Cefpodoxime ProxetilCefpodoxime ProxetilSandoz IncANDACurrent
0781-5439Cefpodoxime ProxetilCefpodoxime ProxetilSandoz IncANDACurrent
0781-5439Cefpodoxime ProxetilCefpodoxime ProxetilSandoz IncANDACurrent
0781-5439Cefpodoxime ProxetilCefpodoxime ProxetilSandoz IncANDACurrent
26637-711Cefpodoxime ProxetilCefpodoxime ProxetilPutney IncANDACurrent
26637-712Cefpodoxime ProxetilCefpodoxime ProxetilPutney IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30665SUPPL2014-02-24
18339SUPPL2014-02-20