ANDA 216631

LUPIN

FDA Drug Application

Application #216631

Application Sponsors

ANDA 216631

LUPIN

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

40MG

0

DOXYCYCLINE

DOXYCYCLINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216631
            [companyName] => LUPIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/07\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-07
        )

)