MICRO LABS FDA Approval ANDA 216232

ANDA 216232

MICRO LABS

FDA Drug Application

Application #216232

Application Sponsors

ANDA 216232MICRO LABS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 10MG BASE0FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE
002CAPSULE;ORALEQ 20MG BASE0FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE
003CAPSULE;ORALEQ 40MG BASE0FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB1
002PrescriptionAB1
003PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216232
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-29
        )

)

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