ANDA 211632

LUPIN LTD

FDA Drug Application

Application #211632

Application Sponsors

ANDA 211632

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 60MG BASE

0

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211632
            [companyName] => LUPIN LTD
            [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":"02\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-08
        )

)