ANDA 211544

GRANULES INDIA LTD

FDA Drug Application

Application #211544

Application Sponsors

ANDA 211544

GRANULES INDIA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

650MG

0

ACETAMINOPHEN

ACETAMINOPHEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GRANULES INDIA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211544
            [companyName] => GRANULES INDIA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"650MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-16
        )

)