HIKMA FDA Approval ANDA 203433

ANDA 203433

HIKMA

FDA Drug Application

Application #203433

Application Sponsors

ANDA 203433HIKMA

Marketing Status

Prescription001
Prescription002

Application Products

001POWDER;INHALATION0.1MG/INH;EQ 0.05MG BASE/INH0FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
002POWDER;INHALATION0.25MG/INH;EQ 0.05MG BASE/INH0FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203433
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE","activeIngredients":"FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE","strength":"0.1MG\/INH;EQ 0.05MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE","activeIngredients":"FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE","strength":"0.25MG\/INH;EQ 0.05MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-17
        )

)

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