ANDA 204402

LUPIN LTD

FDA Drug Application

Application #204402

Application Sponsors

ANDA 204402

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004

Application Products

001	TABLET;ORAL	150MG	0	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE
002	TABLET;ORAL	200MG	0	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE
003	TABLET;ORAL	250MG	0	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE
004	TABLET;ORAL	300MG	0	TENOFOVIR DISOPROXIL FUMARATE	TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-02-06

Submissions Property Types

ORIG

1

Null

1

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204402
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/06\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-02-06
        )

)