ANDA 208075

APOTEX INC

FDA Drug Application

Application #208075

Documents

• Letter: 2019-02-21

Application Sponsors

ANDA 208075

APOTEX INC

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	400MG/VIAL	0	CEFTAROLINE FOSAMIL	CEFTAROLINE FOSAMIL
002	POWDER;INTRAVENOUS	600MG/VIAL	0	CEFTAROLINE FOSAMIL	CEFTAROLINE FOSAMIL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-01-30

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208075
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFTAROLINE FOSAMIL","activeIngredients":"CEFTAROLINE FOSAMIL","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/30\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208075Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-30
        )

)