FDA.reportPublic FDA data

Application 065370

Type
ANDA
Sponsor
AUROBINDO PHARMA

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
16714-394CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLCANDACurrent
16714-394CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLCANDACurrent
16714-394CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLCANDACurrent
16714-394CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLCANDACurrent
16714-395CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLCANDACurrent
16714-395CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLCANDACurrent
16714-395CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLCANDACurrent
16714-395CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLCANDACurrent
52343-019CEFPODOXIME PROXETILCEFPODOXIME PROXETILGen-Source RxANDACurrent
52343-020CEFPODOXIME PROXETILCEFPODOXIME PROXETILGen-Source RxANDACurrent
55289-393CEFPODOXIME PROXETILCEFPODOXIME PROXETILPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-393CEFPODOXIME PROXETILCEFPODOXIME PROXETILPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-393CEFPODOXIME PROXETILCEFPODOXIME PROXETILPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-393CEFPODOXIME PROXETILCEFPODOXIME PROXETILPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-393CEFPODOXIME PROXETILCEFPODOXIME PROXETILPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-393CEFPODOXIME PROXETILCEFPODOXIME PROXETILPD-Rx Pharmaceuticals, InANDACurrent
65862-095CEFPODOXIME PROXETILCEFPODOXIME PROXETILAurobindo Pharma LimitedANDACurrent
65862-095CEFPODOXIME PROXETILCEFPODOXIME PROXETILAurobindo Pharma LimitedANDACurrent
65862-095CEFPODOXIME PROXETILCEFPODOXIME PROXETILAurobindo Pharma LimitedANDACurrent
65862-096CEFPODOXIME PROXETILCEFPODOXIME PROXETILAurobindo Pharma LimitedANDACurrent
65862-096CEFPODOXIME PROXETILCEFPODOXIME PROXETILAurobindo Pharma LimitedANDACurrent
65862-096CEFPODOXIME PROXETILCEFPODOXIME PROXETILAurobindo Pharma LimitedANDACurrent
68071-2742CEFPODOXIME PROXETILCEFPODOXIME PROXETILNuCare Pharmaceuticals,Inc.ANDACurrent
69043-006CEFPODOXIME PROXETILCEFPODOXIME PROXETILCronus Pharma LLCANDACurrent
69043-006CEFPODOXIME PROXETILCEFPODOXIME PROXETILCronus Pharma LLCANDACurrent
69043-006CEFPODOXIME PROXETILCEFPODOXIME PROXETILCronus Pharma LLCANDACurrent
69043-007CEFPODOXIME PROXETILCEFPODOXIME PROXETILCronus Pharma LLCANDACurrent
69043-007CEFPODOXIME PROXETILCEFPODOXIME PROXETILCronus Pharma LLCANDACurrent
69043-007CEFPODOXIME PROXETILCEFPODOXIME PROXETILCronus Pharma LLCANDACurrent