FDA.reportPublic FDA data

Application 079120

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMSOLUTION;ORAL100MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0865LevetiracetamLevetiracetamAtlantic Biologicals CorpsANDACurrent
51991-651LEVETIRACETAMLEVETIRACETAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-651LEVETIRACETAMLEVETIRACETAMBreckenridge PharmaceuticANDACurrent
51991-651LEVETIRACETAMLEVETIRACETAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-651LEVETIRACETAMLEVETIRACETAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-651LEVETIRACETAMLEVETIRACETAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-651LEVETIRACETAMLEVETIRACETAMBreckenridge Pharmaceutical, Inc.ANDACurrent
63629-2073LEVETIRACETAMLEVETIRACETAMBryant Ranch PrepackANDACurrent
63629-2073LEVETIRACETAMLEVETIRACETAMBryant Ranch PrepackANDACurrent
70518-2328LEVETIRACETAMLEVETIRACETAMREMEDYREPACK INC.ANDACurrent
70518-2328LEVETIRACETAMLEVETIRACETAMREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31413ORIG2009-01-21