ANDA 209886

UPSHER SMITH LABS

FDA Drug Application

Application #209886

Application Sponsors

ANDA 209886

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

75MG

0

BEXAROTENE

BEXAROTENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209886
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEXAROTENE","activeIngredients":"BEXAROTENE","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/25\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-25
        )

)