ANDA 204104

MYLAN LABS LTD

FDA Drug Application

Application #204104

Application Sponsors

ANDA 204104

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	POWDER;IV (INFUSION)	25MG/VIAL	0	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE
002	POWDER;IV (INFUSION)	100MG/VIAL	0	BENDAMUSTINE HYDROCHLORIDE	BENDAMUSTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-02-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204104
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"25MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"BENDAMUSTINE HYDROCHLORIDE","activeIngredients":"BENDAMUSTINE HYDROCHLORIDE","strength":"100MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/20\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-20
        )

)