ANDA 210936

SPECGX LLC

FDA Drug Application

Application #210936

Application Sponsors

ANDA 210936

SPECGX LLC

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-01-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210936
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM OXYBATE","activeIngredients":"SODIUM OXYBATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-27
        )

)