ANDA 204029

ABON PHARMS LLC

FDA Drug Application

Application #204029

Documents

• Letter: 2017-05-12
• Label: 2017-05-15

Application Sponsors

ANDA 204029

ABON PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

20MG/20ML (1MG/ML)

0

CLOFARABINE

CLOFARABINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-09

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

ABON PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204029
            [companyName] => ABON PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOFARABINE","activeIngredients":"CLOFARABINE","strength":"20MG\/20ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/09\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204029Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204029Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204029Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-05-09
        )

)