FDA.report

Application 076919

Type
ANDA
Sponsor
MYLAN

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAMLEVETIRACETAMTABLET;ORAL250MGNoNo
002LEVETIRACETAMLEVETIRACETAMTABLET;ORAL500MGNoNo
003LEVETIRACETAMLEVETIRACETAMTABLET;ORAL750MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5613LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5613LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5613LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5613LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5613LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5615LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5615LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5615LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5615LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5615LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5617LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5617LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5617LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5617LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0378-5617LevetiracetamlevetiracetamMylan Pharmaceuticals Inc.ANDACurrent
0615-7550LevetiracetamlevetiracetamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7551LevetiracetamlevetiracetamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7552LevetiracetamlevetiracetamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-820LevetiracetamlevetiracetamMylan Institutional Inc.ANDACurrent
51079-821LevetiracetamlevetiracetamMylan Institutional Inc.ANDACurrent
51079-821LevetiracetamlevetiracetamMylan Institutional Inc.ANDACurrent
51079-821LevetiracetamlevetiracetamMylan Institutional Inc.ANDACurrent
51079-821LevetiracetamlevetiracetamMylan Institutional Inc.ANDACurrent
51079-822LevetiracetamlevetiracetamMylan Institutional Inc.ANDACurrent
51079-822LevetiracetamlevetiracetamMylan Institutional Inc.ANDACurrent
53808-0376LevetiracetamlevetiracetamState of Florida DOH Central PharmacyANDACurrent
55154-5698LevetiracetamlevetiracetamCardinal HealthANDACurrent
55154-5698LevetiracetamlevetiracetamCardinal HealthANDACurrent
55154-5699LevetiracetamlevetiracetamCardinal HealthANDACurrent
55154-5699LevetiracetamlevetiracetamCardinal HealthANDACurrent
55154-5699LevetiracetamlevetiracetamCardinal HealthANDACurrent
55154-5699LevetiracetamlevetiracetamCardinal Health 107, LLCANDACurrent
55154-5699LevetiracetamlevetiracetamCardinal HealthANDACurrent
55154-5699LevetiracetamlevetiracetamCardinal HealthANDACurrent
70518-0430LevetiracetamlevetiracetamREMEDYREPACK INC.ANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.DateStorage
238410ORIG12008-11-25FDA source fallback