FDA.reportPublic FDA data

Application 210568

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-559Cefpodoxime ProxetilCefpodoxime ProxetilAscend Laboratories, LLCANDACurrent
67877-560Cefpodoxime ProxetilCefpodoxime ProxetilAscend Laboratories, LLCANDACurrent
69292-510Cefpodoxime ProxetilCefpodoxime ProxetilAmici Pharmaceuticals, LLC.ANDACurrent
69292-512Cefpodoxime ProxetilCefpodoxime ProxetilAmici Pharmaceuticals, LLC.ANDACurrent
69292-514Cefpodoxime ProxetilCefpodoxime ProxetilAmici Pharmaceuticals, LLC.ANDACurrent
69292-516Cefpodoxime ProxetilCefpodoxime ProxetilAmici Pharmaceuticals, LLC.ANDACurrent