ANDA 208137

MYLAN LABS LTD

FDA Drug Application

Application #208137

Application Sponsors

ANDA 208137

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

160MG/8ML (20MG/ML)

0

DOCETAXEL

DOCETAXEL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208137
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/8ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-01
        )

)