TEVA PHARMS USA FDA Approval ANDA 213948

ANDA 213948

TEVA PHARMS USA

FDA Drug Application

Application #213948

Application Sponsors

ANDA 213948TEVA PHARMS USA

Marketing Status

Prescription001
Prescription002
Prescription003

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
003POWDER;INHALATION0.5MG/INH;EQ 0.05MG BASE/INH0FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TEVA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213948
            [companyName] => TEVA PHARMS USA
            [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"},{"drugName":"FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE","activeIngredients":"FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE","strength":"0.5MG\/INH;EQ 0.05MG BASE\/INH","dosageForm":"POWDER;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-13
        )

)

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