ANDA 212699

LUPIN LTD

FDA Drug Application

Application #212699

Application Sponsors

ANDA 212699

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

200MG/5ML;40MG/5ML

0

SULFAMETHOXAZOLE AND TRIMETHOPRIM

SULFAMETHOXAZOLE; TRIMETHOPRIM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212699
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"200MG\/5ML;40MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-05
        )

)