FDA.reportPublic FDA data

Application 089717

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9554Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9554Leucovorin CalciumLeucovorin CalciumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9554Leucovorin CalciumLeucovorin CalciumHikma Pharmaceuticals USA Inc.ANDACurrent
68001-416Leucovorin CalciumLeucovorin CalciumBluePoint LaboratoriesANDACurrent
68001-416Leucovorin CalciumLeucovorin CalciumBluePoint LaboratoriesANDACurrent
68001-416Leucovorin CalciumLeucovorin CalciumBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39603SUPPL2012-08-30