FDA.reportPublic FDA data

Application 065381

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFPROZILCEFPROZILFOR SUSPENSION;ORAL125MG/5MLNoNo
002CEFPROZILCEFPROZILFOR SUSPENSION;ORAL250MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-396CefprozilCefprozilNorthStar Rx LLCANDACurrent
16714-396CefprozilCefprozilNorthStar Rx LLCANDACurrent
16714-396CefprozilCefprozilNorthStar Rx LLCANDACurrent
16714-397CefprozilCefprozilNorthStar Rx LLCANDACurrent
16714-397CefprozilCefprozilNorthStar Rx LLCANDACurrent
16714-397CefprozilCefprozilNorthStar Rx LLCANDACurrent
50090-3226CefprozilCefprozilA-S Medication SolutionsANDACurrent
57237-034CefprozilCefprozilRising Health, LLCANDACurrent
57237-034CefprozilCefprozilRising Health, LLCANDACurrent
57237-034CefprozilCefprozilRising Health, LLCANDACurrent
57237-035CefprozilCefprozilRising Health, LLCANDACurrent
57237-035CefprozilCefprozilRising Health, LLCANDACurrent
57237-035CefprozilCefprozilRising Health, LLCANDACurrent
65862-099CefprozilCefprozilAurobindo Pharma LimitedANDACurrent
65862-099CefprozilCefprozilAurobindo Pharma LimitedANDACurrent
65862-099CefprozilCefprozilAurobindo Pharma LimitedANDACurrent
65862-100CefprozilCefprozilAurobindo Pharma LimitedANDACurrent
65862-100CefprozilCefprozilAurobindo Pharma LimitedANDACurrent
65862-100CefprozilCefprozilAurobindo Pharma LimitedANDACurrent