BELCHER FDA Approval ANDA 206938

ANDA 206938

BELCHER

FDA Drug Application

Application #206938

Application Sponsors

ANDA 206938BELCHER

Marketing Status

Prescription001
Prescription002

Application Products

001FOR SUSPENSION;ORAL100MG/5ML0CEFIXIMECEFIXIME
002FOR SUSPENSION;ORAL200MG/5ML0CEFIXIMECEFIXIME

FDA Submissions

UNKNOWN; ORIG1AP2017-02-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BELCHER
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206938
            [companyName] => BELCHER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFIXIME","activeIngredients":"CEFIXIME","strength":"100MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFIXIME","activeIngredients":"CEFIXIME","strength":"200MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-02-06
        )

)

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