ANDA 203824

HIKMA PHARMS

FDA Drug Application

Application #203824

Application Sponsors

ANDA 203824

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

875MG;EQ 125MG BASE

0

AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-08-23

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203824
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"875MG;EQ 125MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/23\/2016","submission":"SUPPL-1","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-08-23
        )

)