ANDA 209439

CIPLA

FDA Drug Application

Application #209439

Application Sponsors

ANDA 209439

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 15 UNITS BASE/VIAL

0

BLEOMYCIN SULFATE

BLEOMYCIN SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209439
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BLEOMYCIN SULFATE","activeIngredients":"BLEOMYCIN SULFATE","strength":"EQ 15 UNITS BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-11
        )

)