ANDA 206551

ACCORD HLTHCARE

FDA Drug Application

Application #206551

Documents

• Letter: 2016-05-04
• Letter: 2017-11-27

Application Sponsors

ANDA 206551

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

250MG/VIAL

0

BIVALIRUDIN

BIVALIRUDIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206551
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIVALIRUDIN","activeIngredients":"BIVALIRUDIN","strength":"250MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206551Orig1s000TAltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206551Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-22
        )

)