FDA.reportPublic FDA data

Application 203576

Type
ANDA
Sponsor
MYLAN TEORANTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMSOLUTION;INTRAVENOUSEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)NoNo
002LEVOLEUCOVORIN CALCIUMLEVOLEUCOVORIN CALCIUMSOLUTION;INTRAVENOUSEQ 250MG BASE/25ML (EQ 10MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-600LEVOLEUCOVORIN CALCIUMLevoleucovorinMylan Institutional LLCANDACurrent
67457-601LEVOLEUCOVORIN CALCIUMLevoleucovorinMylan Institutional LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10238ORIG2015-10-22