TORRENT FDA Approval ANDA 206937

ANDA 206937

TORRENT

FDA Drug Application

Application #206937

Application Sponsors

ANDA 206937TORRENT

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 10MG BASE0FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE
002TABLET;ORALEQ 20MG BASE0FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2016-10-21STANDARD
LABELING; LabelingSUPPL3AP2021-09-02STANDARD
LABELING; LabelingSUPPL6AP2021-09-21STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15
SUPPL6Null7

TE Codes

001PrescriptionAB1
002PrescriptionAB1

CDER Filings

TORRENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206937
            [companyName] => TORRENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-21
        )

)

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