ANDA 090831

APOTEX INC

FDA Drug Application

Application #090831

Application Sponsors

ANDA 090831

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

ORIG

1

TA

2018-07-31

Submissions Property Types

ORIG

1

Null

19

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90831
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM CARBONATE; RISEDRONATE SODIUM","activeIngredients":"CALCIUM CARBONATE;RISEDRONATE SODIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CALCIUM CARBONATE; RISEDRONATE SODIUM","submission":"CALCIUM CARBONATE;RISEDRONATE SODIUM","actionType":"UNKNOWN","submissionClassification":"UNKNOWN","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)