FDA.reportPublic FDA data

Application 065396

Type
ANDA
Sponsor
LUPIN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-181CefadroxilCefadroxilLupin Pharmaceuticals, Inc.ANDACurrent
68180-181CefadroxilCefadroxilLupin Pharmaceuticals, Inc.ANDACurrent
68180-182CefadroxilCefadroxilLupin Pharmaceuticals, Inc.ANDACurrent
68180-182CefadroxilCefadroxilLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39423SUPPL2014-04-22
8397ORIG2010-11-10
39422ORIG2010-10-26