FDA.reportPublic FDA data

Application 091261

Type
ANDA
Sponsor
APOTEX INC

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
60429-349LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-349LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-349LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-349LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-349LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-350LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-350LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-350LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-350LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60429-350LevetiracetamlevetiracetamGolden State Medical Supply, Inc.ANDACurrent
60505-3280LevetiracetamLevetiracetamApotex Corp.ANDACurrent
60505-3280LevetiracetamLevetiracetamApotex Corp.ANDACurrent
60505-3280LevetiracetamLevetiracetamApotex Corp.ANDACurrent
60505-3280LevetiracetamLevetiracetamApotex Corp.ANDACurrent
60505-3517LevetiracetamLevetiracetamApotex Corp.ANDACurrent
60505-3517LevetiracetamLevetiracetamApotex Corp.ANDACurrent
60505-3517LevetiracetamLevetiracetamApotex Corp.ANDACurrent
60505-3517LevetiracetamLevetiracetamApotex Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9328ORIG2011-09-28