ANDA 212435

GLAND PHARMA LTD

FDA Drug Application

Application #212435

Documents

• Letter: 2020-08-24

Application Sponsors

ANDA 212435

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/100ML

0

METRONIDAZOLE IN PLASTIC CONTAINER

METRONIDAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212435
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRONIDAZOLE IN PLASTIC CONTAINER","activeIngredients":"METRONIDAZOLE","strength":"500MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-03
        )

)