ANDA 205037

MYLAN LABS LTD

FDA Drug Application

Application #205037

Application Sponsors

ANDA 205037

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

500MG/VIAL

0

DAPTOMYCIN

DAPTOMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-06-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205037
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-05
        )

)