ANDA 209304

TELIGENT PHARMA INC

FDA Drug Application

Application #209304

Application Sponsors

ANDA 209304

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

EQ 0.1% BASE

0

GENTAMICIN SULFATE

GENTAMICIN SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-10-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209304
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 0.1% BASE","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-18
        )

)