Application 065409

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFPODOXIME PROXETILCEFPODOXIME PROXETILFOR SUSPENSION;ORALEQ 50MG BASE/5MLNoNo
002CEFPODOXIME PROXETILCEFPODOXIME PROXETILFOR SUSPENSION;ORALEQ 100MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-402Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-402Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-402Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-402Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-403Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-403Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-403Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-403Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
64980-402Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-402Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-402Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-403Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-403Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-403Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
65862-140Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-140Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-140Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-141Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-141Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-141Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent