FDA.reportPublic FDA data

Application 203563

Type
ANDA
Sponsor
SANDOZ INC

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)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3201LevoleucovorinLevoleucovorinSandoz IncANDACurrent
0781-3201LevoleucovorinLevoleucovorinSandoz IncANDACurrent
0781-3201LevoleucovorinLevoleucovorinSandoz IncANDACurrent
0781-3201LevoleucovorinLevoleucovorinSandoz IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40311ORIG2015-03-12
32440ORIG2015-03-11
10232ORIG2015-03-11