ANDA 210228

UNIQUE PHARM LABS

FDA Drug Application

Application #210228

Application Sponsors

ANDA 210228

UNIQUE PHARM LABS

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

EQ 150MG BASE

0

RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

UNIQUE PHARM LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210228
            [companyName] => UNIQUE PHARM LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RANITIDINE HYDROCHLORIDE","activeIngredients":"RANITIDINE HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-30
        )

)