ANDA 203495

AVANTHI INC

FDA Drug Application

Application #203495

Application Sponsors

ANDA 203495

AVANTHI INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

8MG

0

LOMAIRA

PHENTERMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-12

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AA

CDER Filings

AVANTHI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203495
            [companyName] => AVANTHI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOMAIRA","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/12\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-12
        )

)