FDA.reportPublic FDA data

Application 065349

Type
ANDA
Sponsor
AUROBINDO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEFOR SUSPENSION;ORALEQ 250MG BASE/5MLNoNo
002CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEFOR SUSPENSION;ORALEQ 500MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-389CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
16714-389CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
16714-389CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
16714-390CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
16714-390CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
16714-390CefadroxilCefadroxilNorthStar Rx LLCANDACurrent
57237-097CefadroxilCefadroxilRising Health, LLCANDACurrent
57237-097CefadroxilCefadroxilRising Health, LLCANDACurrent
57237-097CefadroxilCefadroxilRising Health, LLCANDACurrent
57237-098CefadroxilCefadroxilRising Health, LLCANDACurrent
57237-098CefadroxilCefadroxilRising Health, LLCANDACurrent
57237-098CefadroxilCefadroxilRising Health, LLCANDACurrent
65862-083CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent
65862-083CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent
65862-083CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent
65862-084CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent
65862-084CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent
65862-084CefadroxilCefadroxilAurobindo Pharma LimitedANDACurrent