ANDA 211051

TEVA PHARMS USA

FDA Drug Application

Application #211051

Application Sponsors

ANDA 211051

TEVA PHARMS USA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 60MG BASE

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211051
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOXETINE HYDROCHLORIDE","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/03\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-03
        )

)