FDA.reportPublic FDA data

Application 091399

Type
ANDA
Sponsor
LUPIN LTD

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
57297-117LevetiracetamLevetiracetamLUPIN LIMITEDANDACurrent
57297-118LevetiracetamLevetiracetamLUPIN LIMITEDANDACurrent
68001-113LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-113LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-113LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-113LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-114LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-114LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-114LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68001-114LevetiracetamLevetiracetamBluePoint LaboratoriesANDACurrent
68180-117LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-117LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-117LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-117LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-118LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-118LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-118LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
68180-118LevetiracetamLevetiracetamLupin Pharmaceuticals, Inc.ANDACurrent
70518-0648LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent
70518-0648LevetiracetamLevetiracetamREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43251ORIG2012-06-22
31527ORIG2011-09-21