LANNETT CO INC FDA Approval ANDA 077849

ANDA 077849

LANNETT CO INC

FDA Drug Application

Application #077849

Application Sponsors

ANDA 077849LANNETT CO INC

Marketing Status

Prescription001

Application Products

001SOLUTION;ORALEQ 20MG BASE/5ML0FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2007-02-09
LABELING; LabelingSUPPL2AP2008-05-29
LABELING; LabelingSUPPL3AP2009-03-11
LABELING; LabelingSUPPL4AP2009-03-11
LABELING; LabelingSUPPL6AP2014-07-16STANDARD
LABELING; LabelingSUPPL8AP2014-07-18STANDARD
LABELING; LabelingSUPPL9AP2016-12-27STANDARD
LABELING; LabelingSUPPL10AP2017-01-04STANDARD
LABELING; LabelingSUPPL11AP2021-09-07STANDARD
LABELING; LabelingSUPPL12AP2021-09-07STANDARD
LABELING; LabelingSUPPL13AP2021-09-21STANDARD

Submissions Property Types

SUPPL6Null7
SUPPL8Null7
SUPPL9Null7
SUPPL10Null7
SUPPL11Null7
SUPPL12Null7
SUPPL13Null7

TE Codes

001PrescriptionAA

CDER Filings

LANNETT CO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77849
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOXETINE HYDROCHLORIDE","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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