ANDA 209498

QILU

FDA Drug Application

Application #209498

Application Sponsors

ANDA 209498

QILU

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209498
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-02
        )

)