ANDA 214039

GRANULES

FDA Drug Application

Application #214039

Application Sponsors

ANDA 214039

GRANULES

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

250MG;250MG;65MG

0

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

ACETAMINOPHEN; ASPIRIN; CAFFEINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

GRANULES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214039
            [companyName] => GRANULES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN, ASPIRIN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; ASPIRIN; CAFFEINE","strength":"250MG;250MG;65MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-23
        )

)