ANDA 208366

APOTEX INC

FDA Drug Application

Application #208366

Documents

• Letter: 2018-05-11

Application Sponsors

ANDA 208366

APOTEX INC

Marketing Status

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

Application Products

001	INJECTABLE;INTRAVENOUS	EQ 50MG BASE/VIAL	0	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM
002	INJECTABLE;INTRAVENOUS	EQ 100MG BASE/VIAL	0	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-04-20

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] => 208366
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICAFUNGIN","activeIngredients":"MICAFUNGIN","strength":"50MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"MICAFUNGIN","activeIngredients":"MICAFUNGIN","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/20\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208366Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-20
        )

)