Application 089384

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUCOVORIN CALCIUMLEUCOVORIN CALCIUMINJECTABLE;INJECTIONEQ 50MG BASE/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9555Leucovorin CalciumLeucovorin CalciumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9555Leucovorin CalciumLeucovorin CalciumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9555Leucovorin CalciumLeucovorin CalciumHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39600SUPPL2012-08-30