ANDA 211309

SAPTALIS PHARMS

FDA Drug Application

Application #211309

Application Sponsors

ANDA 211309

SAPTALIS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

500MG/5ML

0

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-03

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

SAPTALIS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211309
            [companyName] => SAPTALIS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-03
        )

)