ANDA 201991

INVENTIA

FDA Drug Application

Application #201991

Application Sponsors

ANDA 201991

INVENTIA

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

500MG

0

METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2012-01-18

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB1

CDER Filings

INVENTIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201991
            [companyName] => INVENTIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/18\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-01-18
        )

)