ANDA 209106

LUPIN LTD

FDA Drug Application

Application #209106

Application Sponsors

ANDA 209106

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT, AUGMENTED;TOPICAL

EQ 0.05% BASE

0

BETAMETHASONE DIPROPIONATE

BETAMETHASONE DIPROPIONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209106
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"OINTMENT, AUGMENTED;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-18
        )

)