ANDA 211278

TEVA PHARMS USA

FDA Drug Application

Application #211278

Application Sponsors

ANDA 211278

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

26.6MG;800MG

0

IBUPROFEN AND FAMOTIDINE

FAMOTIDINE; IBUPROFEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211278
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN AND FAMOTIDINE","activeIngredients":"FAMOTIDINE; IBUPROFEN","strength":"26.6MG;800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-29
        )

)