Application 091291

Type
ANDA
Sponsor
VIRTUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL500MGNoNo
002LEVETIRACETAMLEVETIRACETAMTABLET, EXTENDED RELEASE;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-204LevetiracetamlevetiracetamPar Pharmaceutical Inc.ANDACurrent
49884-205LevetiracetamlevetiracetamPar Pharmaceutical Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31522ORIG2011-10-03