ANDA 207344

FRESENIUS KABI USA

FDA Drug Application

Application #207344

Documents

• Letter: 2019-06-17

Application Sponsors

ANDA 207344

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 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

AP

2019-05-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207344
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICAFUNGIN SODIUM","activeIngredients":"MICAFUNGIN SODIUM","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MICAFUNGIN SODIUM","activeIngredients":"MICAFUNGIN SODIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207344Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-17
        )

)