ANDA 212428

GLASSHOUSE PHARMACEUTICALS LTD CANADA

FDA Drug Application

Application #212428

Application Sponsors

ANDA 212428

GLASSHOUSE PHARMACEUTICALS LTD CANADA

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SUSPENSION;ORAL

300MG/5ML

0

OXCARBAZEPINE

OXCARBAZEPINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-04-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

GLASSHOUSE PHARMACEUTICALS LTD CANADA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212428
            [companyName] => GLASSHOUSE PHARMACEUTICALS LTD CANADA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/15\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-15
        )

)