ANDA 205459

APOTEX

FDA Drug Application

Application #205459

Application Sponsors

ANDA 205459

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

10MG

0

ADEFOVIR DIPIVOXIL

ADEFOVIR DIPIVOXIL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205459
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADEFOVIR DIPIVOXIL","activeIngredients":"ADEFOVIR DIPIVOXIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-06
        )

)