ANDA 212612

GLAND PHARMA LTD

FDA Drug Application

Application #212612

Application Sponsors

ANDA 212612

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.2MG/ML

0

GLYCOPYRROLATE

GLYCOPYRROLATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212612
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-30
        )

)