ANDA 204876

APOTEX

FDA Drug Application

Application #204876

Documents

• Letter: 2017-07-11

Application Sponsors

ANDA 204876

APOTEX

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAVENOUS

250MG/VIAL

0

BIVALIRUDIN

BIVALIRUDIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-07-06
LABELING; Labeling	SUPPL	2	AP	2020-09-17	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204876
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIVALIRUDIN","activeIngredients":"BIVALIRUDIN","strength":"250MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204876Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/17\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-17
        )

)