ANDA 209532

APOTEX INC

FDA Drug Application

Application #209532

Documents

• Letter: 2022-11-28

Application Sponsors

ANDA 209532

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

250MG

0

GEFITINIB

GEFITINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-03-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209532
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEFITINIB","activeIngredients":"GEFITINIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-10
        )

)