FDA.reportPublic FDA data

Application 040335

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUM PRESERVATIVE FREELEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 350MG BASE/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9552Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9552Leucovorin CalciumLeucovorin CalciumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9552Leucovorin CalciumLeucovorin CalciumHikma Pharmaceuticals USA Inc.ANDACurrent
68001-418Leucovorin CalciumLeucovorin CalciumBluePoint LaboratoriesANDACurrent
68001-418Leucovorin CalciumLeucovorin CalciumBluePoint LaboratoriesANDACurrent
68001-418Leucovorin CalciumLeucovorin CalciumBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38885SUPPL2012-08-30
29932ORIG2000-04-20