ANDA 209975

TELIGENT PHARMA INC

FDA Drug Application

Application #209975

Application Sponsors

ANDA 209975

TELIGENT PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SHAMPOO;TOPICAL

1%

0

CICLOPIROX

CICLOPIROX

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-04-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

TELIGENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209975
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CICLOPIROX","activeIngredients":"CICLOPIROX","strength":"1%","dosageForm":"SHAMPOO;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-05
        )

)