TELIGENT PHARMA INC FDA Approval ANDA 209233

ANDA 209233

TELIGENT PHARMA INC

FDA Drug Application

Application #209233

Application Sponsors

ANDA 209233TELIGENT PHARMA INC

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICALEQ 0.1% BASE0GENTAMICIN SULFATEGENTAMICIN SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2018-12-31STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

TELIGENT PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209233
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 0.1% BASE","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-31
        )

)

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